Knee Implant Manufacturing & OEM Supply

Knee Implant Manufacturing & OEM Supply

Knee Implant Manufacturing & OEM Supply

ShinvaUnited supplies knee, hip, spine and trauma implant systems to OEM, private-label, distribution and tender buyers, and the femoral component (PS) is the knee-side reference SKU — a medical-grade CoCrMo implant in the XU Knee System with published sizing, resection and compatibility data. Sourcing teams shortlisting total knee replacement implant manufacturers for a new programme can compare the documented specification below, while procurement groups benchmarking knee replacement implant manufacturers on documentation and traceability can work through the capability, engagement and quality modules before samples are committed.

Buyer types OEM · Private label · Distributor · GPO tender
Reference SKU Femoral component (PS), XU Knee System
Core material Medical-grade CoCrMo
Enquiry input Drawing, sizes, volumes, markets
Femoral component,PS,Shinvaunited,Femoral component,PS

Manufacturing Capability Matrix

Each row below is stated for the femoral component (PS). Rows marked as project scope are agreed with your team during drawing and specification review rather than published in advance, so the grid shows the production system behind the SKU instead of a wish list.

Production stage Documented scope Basis
Raw material Medical-grade CoCrMo (cobalt chromium molybdenum), selected for structural strength and biocompatibility Published
Forming & sizing Left and right components in sizes #1–#6 plus half sizes #1.5–#5.5; AP/ML ratio optimised to anatomical characteristics Published
Articular geometry Curve-on-curve post-cam contact; optimised intercondylar notch and increased fillet radii to reduce stress concentration Published
Bone-conserving profile 9 mm distal and posterior condyle resection design that preserves bone stock Published
Sterile packaging & labelling Sterile packaging with labelling that supports clinical traceability Published
Batch records & documentation release Batch traceability and documentation aligned to regulatory quality standards; package contents scoped per market Project scope
Femoral component (PS) knee implant detail showing articular geometry

Any material, coating or bearing option outside the rows above is confirmed case by case during drawing and specification review; it is not part of the published specification for this SKU.

OEM / ODM Engagement Workflow

Seven steps take a project from first enquiry to documentation release. Steps one and two belong to the buyer; everything downstream runs on the specification agreed at step two, so the fastest route to a quote is a complete drawing and demand plan.

1

Inquiry

Send the product family, target sizes, annual volume and destination markets through the contact page.

2

Drawing & specification review

Side and size range, resection targets, articulation design intent, packaging and labelling requirements.

3

DFM feedback

Anatomical sizing and post-cam geometry are reviewed against your drawing; material and tolerances are confirmed.

4

Tooling & sample build

Sample components are produced for fit and geometry review before any serial release is scheduled.

5

Validation & approval

Sample approval and the documentation scope for your target market are agreed and recorded.

6

Serial production

Repeat batches of the approved specification in CoCrMo with sterile packaging and consistent labelling.

7

Documentation release

Batch traceability records and labelling documentation are released with each shipment.

What to send with your enquiry

  • Product family and side (left / right) with the required size list
  • First order quantity and expected annual demand
  • Destination markets, for labelling language and documentation scope
  • Drawing or reference sample with critical dimensions and tolerances
  • Packaging, sterile-barrier and labelling requirements
  • Target launch date or tender deadline

Steps and validation scope are set during enquiry. Commercial parameters such as tooling lead time, MOQ and packaging configuration are confirmed per project rather than published in advance.

Quality, Traceability & Regulatory Documentation

Two lists for procurement and tender reviewers: what the product page documents for this SKU, and what stays with you as the buyer. Checking both against your own checklist keeps the scope honest before an order is placed.

Documented for the femoral component (PS)

  • Medical-grade CoCrMo material, selected for structural strength and biocompatibility
  • Sterile packaging for the finished implant
  • Batch traceability across production
  • Adherence to regulatory quality standards, as referenced on the product page
  • Clinical traceability and compliance statements

Confirmed with you as the buyer

  • Market registration and certification scope for your destination countries
  • Which certificate copies or declarations your tender or hospital committee requires
  • Labelling language and pack configuration
  • Sample, dimensional and validation approval before serial release
  • Batch record retention requirements at your facility

Requests for the current documentation package should go through the contact page and name the market, tender or registration route, so the scope can be confirmed before an order is placed.

Femoral Component (PS): What the Specification Covers

The femoral component (PS) is the knee-side SKU buyers can verify today: a posterior stabilized CoCrMo implant with a full and half-size range, a bone-conserving resection profile and documented compatibility inside the XU Knee System.

Femoral component,PS,Shinvaunited,Femoral component,PS
  • Anatomical sizing design AP/ML ratio optimised to anatomical characteristics, with half-size options that improve femoral coverage.
  • Bone preservation Optimised intercondylar notch, increased fillet radii to reduce stress concentration, and a 9 mm distal and posterior condyle resection.
  • Optimised post-cam design Curve-on-curve contact between post and cam reduces contact stress and helps minimise polyethylene wear.
  • High-flexion performance Designed to support high-flexion motion up to 155°.
Open the Product Page
Specification Published value
Application scope Total knee arthroplasty (TKA); primary and revision procedures
Material CoCrMo (medical-grade cobalt chromium molybdenum)
Design concept Posterior stabilized, with posterior cruciate ligament substitution
Sizes Left and right #1, #2, #3, #4, #5, #6 and half sizes #1.5, #2.5, #3.5, #4.5, #5.5
Bone resection 9 mm distal and posterior condyle resection
Flexion capability Supports knee flexion up to 155°
Compatible system XU Knee System; compatible with PS tibial inserts and tibial baseplates
Intended applications Osteoarthritis, rheumatoid arthritis and post-traumatic arthritis

XU Knee System Integration & Compatibility Reference

The product page states one integration rule: the femoral component (PS) interlocks with compatible PS tibial inserts and tibial baseplates. This is the three-part assembly your ordering list has to cover.

Tibial baseplate XU Knee System foundation component
interlocks with
PS tibial insert Posterior stabilized bearing
interlocks with
Femoral component (PS) CoCrMo, left / right #1–#6 plus half sizes
Component Role in the assembly Stated compatibility
Femoral component (PS) Posterior stabilized femoral implant in medical-grade CoCrMo; left and right #1–#6 plus half sizes #1.5–#5.5 Interlocks with compatible PS tibial inserts and tibial baseplates in the XU Knee System
PS tibial insert Posterior stabilized bearing component of the XU Knee System Listed as compatible with the femoral component (PS)
Tibial baseplate Tibial foundation component of the XU Knee System Listed as compatible with the femoral component (PS)

The product page does not publish size-to-size pairing rules. Confirm which femoral size pairs with which insert and baseplate against the current XU Knee System technique guide before placing an order.

Scenario-to-Specification Decision Guide

Match the clinical or commercial situation on the left to the specification you need to confirm before ordering, and anchor the decision on the published fact in the third column.

Scenario Confirm first Published fact to anchor on
Primary TKA for osteoarthritis Patient side and AP/ML size across the full and half-size range Designed for primary TKA; left and right #1–#6 plus half sizes #1.5–#5.5
Revision TKA Revision scope, bone stock and component pairing with the existing tibial side Stated for both primary and revision total knee arthroplasty
Rheumatoid or post-traumatic arthritis Soft-tissue condition and the constraint the case requires Both conditions listed among the intended applications
High-flexion patients Expected flexion range and post-cam behaviour through the arc Supports knee flexion up to 155° with curve-on-curve post-cam contact
Bone-stock preservation priority Planned distal and posterior resection depth 9 mm distal and posterior condyle resection design
OEM / private-label programme Drawing, size list, packaging and labelling for your release Same CoCrMo specification, produced to the release agreed with your team

Anything not covered above — coatings, alternative materials or non-standard sizes — is confirmed with your drawings during specification review.

Start a Knee Implant OEM or Supply Project

Send your drawing, size list, first-order quantity and destination markets. We will come back with the specification questions, the packaging and labelling scope, and the documentation package your market or tender requires.

Related Reading

Three notes to help clarify product requirements before contacting the supplier.

Full and Half Sizes Improve Anatomical Fit in PS Femoral Components

Full and half sizes in PS femoral components exist because AP and ML anatomy rarely scales in perfect proportion.

Read article

Curve-on-Curve Post-Cam Contact and Joint Stress in PS Knee Implants

Curve-on-curve post-cam contact changes how a posterior stabilized knee implant spreads load, and that geometry shapes polyethylene wear over time.

Read article

How CoCrMo Alloy Supports Wear Resistance in PS Knee Femoral Components

Cobalt chromium molybdenum alloy gives posterior stabilized knee femoral components the hard, corrosion-resistant bearing surface needed to work against polyethylene.

Read article

Frequently Asked Questions

Can shinvaunited manufacture femoral components to our own drawings and sizes?

Oem and odm enquiries are reviewed from your drawing, required sizes and release documentation. Send the specification through the contact us page: the femoral component (ps) is the knee-side reference sku, so material, sizing, packaging and documentation scope can be confirmed against it before tooling or sampling is discussed.

What material is the femoral component (ps) made from?

Medical-grade cocrmo (cobalt chromium molybdenum), selected for structural strength and biocompatibility.

Which sizes and side options are available?

Left and right femoral components in sizes #1, #2, #3, #4, #5 and #6, plus half sizes #1.5, #2.5, #3.5, #4.5 and #5.5, which improve femoral coverage where a full size does not fit.

What is the femoral component (ps) compatible with inside the xu knee system?

It interlocks with compatible ps tibial inserts and tibial baseplates. The product page does not publish size-to-size pairing rules, so confirm the femoral, insert and baseplate combination against the current xu knee system technique guide before ordering.

How much bone does the design resect, and how much flexion does it support?

The design uses a 9 mm distal and posterior condyle resection, with an optimised intercondylar notch and increased fillet radii to reduce stress concentration. It supports knee flexion up to 155°.

What documentation ships with an order?

Orders are released with sterile packaging, batch traceability and documentation aligned to regulatory quality standards. Market registration, certificate copies and labelling language are confirmed with you before serial production; requests go through the contact us page.

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