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36MM COCR Femoral Head And 36MM Acetabular Insert

by Hayes Medical, Inc.

510(k) K070061

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070061 Date31 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LWJ
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device consists of a 36 mm cobalt‑chromium‑molybdenum (CoCrMo) femoral head paired with a compatible 36 mm acetabular insert made of cross‑linked ultra‑high‑molecular‑weight polyethylene (UHMWPE). It is intended for use as a component set in total hip arthroplasty, providing articulation between the femoral and acetabular sides of the joint.

The system is supplied by Hayes Medical, Inc. and was cleared through the FDA 510(k) pathway (decision date 31 Jan 2007, K‑number K070061, product code LWJ). The 36 mm size adds a new head dimension and includes compatible acetabular inserts with 10° and 20° hooded configurations. The components are provided as sterile, implantable devices for surgical implantation.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What sizes and hood angles are available for this hip component set?

    The set is supplied only in a 36 mm diameter for both the femoral head and the acetabular insert. The insert is offered with two hooded configurations, providing 10° or 20° coverage to accommodate different surgical approaches and patient anatomy.

  • Is the device provided sterile and ready for implantation?

    Yes, Hayes Medical ships the femoral head and acetabular insert as sterile, implantable devices. Sterility is maintained through the packaging, allowing the surgeon to use the components directly in the operating room without additional processing.

  • Can the components be reused or are they single‑use only?

    Both the CoCr femoral head and the UHMWPE acetabular insert are intended for single‑use implantation. Re‑sterilization is not recommended because it could compromise material integrity and the precise articulation surface required for a total hip arthroplasty.

  • What regulatory pathway was used for clearance of this product?

    The device was cleared through the FDA 510(k) pathway, with decision date 31 January 2007 (K‑number K070061, product code LWJ). This indicates it was found substantially equivalent to a legally marketed predicate device.