510(k) K093235 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
RINGLOC + HYBRID ACETABULAR SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 30, 2010 |
| Received | Oct 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Zimmer Biomet, Inc. PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62
The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revisi Terminated |
LPH | None listed |
| Aug 29, 2015 | Biomet, Inc. Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. Terminated |
LPH | None listed |
| Feb 17, 2015 | Biomet, Inc. Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104146, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104148, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104152, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104154, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104158, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104160, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104162, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104164, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, sterile, REF 16-104166, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented use, sterile, REF 16-104170, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-116046, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc Ac Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, REF 16-116048, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116050, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116052, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116054, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116056, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116058, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060, Biomet Orthopedics, Warsaw, IN. Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116062, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116064, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116066, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116068, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116070, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116072, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
| Jun 8, 2011 | Biomet, Inc. Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116076, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.