Company ยท US
OMNIlife science Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2021. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 4 |
| FZX | Guide, Surgical, Instrument | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2021 | K201611 | Apex Knee System Omnilife Science | JWH |
| Dec 21, 2017 | K172467 | OMNI ARC Anteverted Neck Hip Stem Omnilife Science | LZO |
| Aug 17, 2017 | K171156 | OMNI Anseris Hip Stem Omnilife Science | LZO |
| Apr 26, 2017 | K163332 | Apex Revision Knee System Omnilife Science | JWH |
| Dec 21, 2015 | K153437 | Apex Revision Knee System Omnilife Science | JWH |
| Mar 13, 2014 | K133381 | OMNI ARC MONOBLOCK HIP STEM Omnilife Science | LZO |
| Aug 15, 2007 | K062489 | APEX HCLA ACETABULAR CUP LINERS Omnilife Science | LPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2021 | OmniLife Science 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 unceme Terminated |
LPH | K041950 |
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-24928 Terminated |
LZO | K111572 |
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-24728 Terminated |
LZO | K111572 |
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-25128 Terminated |
LZO | K111572 |
| Sep 11, 2019 | OMNIlife science Inc. OMNI Hip System
Model, Catalogue, or Order Number(s): HC-00070
Intended for use as the femoral component of a primary or revision total hip replacement. Terminated |
LPH | K060072 |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
ApeX-LNK crosslinked Acetabular Insert, 10 deg hood;
Product Code : H5-54840 Terminated |
LPH | K100555 |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Insert Liner 51-28;
Product code: H6-25128 Terminated |
LZO | K111572 |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Liner 53-28;
Product code: H6-25328 Terminated |
LZO | K111572 |
| Apr 12, 2019 | OMNIlife science Inc. OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock C Terminated |
OLO | K090953 |
| Nov 29, 2018 | OMNIlife science Inc. OMNI K1 Broach Handle, Product Code HS-10054 Terminated |
LXH | None listed |
| May 18, 2018 | OMNIlife science Inc. OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836
Product Usage:
The Apex Hip System is intended for primary or revision total hip repla Terminated |
LPH | K101976 |
| Nov 20, 2017 | OMNIlife science Inc. Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L
The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intende Terminated |
JWH | K060192 |
| Aug 24, 2015 | Omnilife Science Inc. Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024
Product Usage:
The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip System Terminated |
FZX | None listed |
| Aug 24, 2015 | Omnilife Science Inc. Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022
Product Usage:
The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Syste Terminated |
FZX | None listed |
| Aug 21, 2015 | Omnilife Science Inc. 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 Mo Terminated |
LPH | K112779 |
| Jul 14, 2015 | Omnilife Science Inc. Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA
Product Usage:
The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is Terminated |
LZO | K090845 |
| Aug 15, 2014 | Omnilife Science Inc. Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Terminated |
LZO | K090845 |