APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)— 510(k) K112779

Clearance details

Applicant

Omnlife Science

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2011-09-26

Decision date

2011-12-02

Decision

Substantially Equivalent

Clearance type

Special

Location

East Taunton, 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

• K142201 — OMNI Interface Acetabular System2015-01-26
• K101994 — APEX KNEE MODULAR TIBIA SYSTEM2010-09-28
• K101575 — APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,3040102010-06-30
• K100151 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)2010-05-28
• K073602 — MODIFICATION TO: APEX KNEE SYSTEM2008-02-14

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-2445-2015 — APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.Class II·Terminated·Omnilife Science Inc.·20150604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112779.