APEX K2 HIP SYSTEM— 510(k) K041950

Clearance details

Applicant

Apex Surgical, LLC

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2004-07-20

Decision date

2004-12-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lakeville, MA, US

• K253630 — Mpact 3D Metal Foam2026-08-28
• K254043 — TRIVANCE Hip Stem2026-08-04
• K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
• K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
• K251270 — Taperloc® Complete Hip Stem2026-05-19

• K043123 — APEX MODULAR HA HIP STEM2005-02-10
• K031110 — APEX MODULAR ACETABULAR CUP2003-05-22
• K012918 — APEX MODULAR ALUMINA FEMORAL HEAD2001-11-27
• K003923 — APEX MODULAR ZIRCONIA FEMORAL HEAD2001-03-20
• K000788 — APEX MODULAR HIP STEM2000-08-04

Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0237-2022 — OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.Class II·Terminated·OmniLife Science·20211001

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041950.