510(k) Report

FDA applicant

Omnlife Science

East Taunton, MA6 decisions2008–20152 recalls

FDA records 6 decisions for Omnlife Science (East Taunton, MA) from 2008 to 2015: 6 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 15 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Omnlife Science’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12010: 32011: 12015: 1
2008high 3 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2015: 12025: 1
2008high 1 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Omnlife Science by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision

Whose devices does it build on?

Its devices cite 15 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073602Modification to: Apex Knee SystemOmnlife Science · 20083cite it
  • K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010Omnlife Science · 20103cite it
  • K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science · 20112cite it
  • K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science · 20102cite it
  • K142201OMNI Interface Acetabular SystemOmnlife Science · 20151cites it
  • K101994Apex Knee Modular Tibia SystemOmnlife Science · 20101cites it

What has FDA decided for it lately?

  • K142201OMNI Interface Acetabular SystemOmnlife Science · 2015
  • K112779Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science · 20111 recall
  • K101994Apex Knee Modular Tibia SystemOmnlife Science · 20101 recall
  • K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010Omnlife Science · 2010
  • K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science · 2010
  • K073602Modification to: Apex Knee SystemOmnlife Science · 2008

All 6 as Omnlife Science →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K101994Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130…May 23, 2025Class II
  • K112779APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354…Jun 4, 2015Class II