510(k) K934765 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
TRILOGY ACETABULAR SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 29, 1994 |
| Received | Oct 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Trilogy self-tapping bone screw
Bone screw 4.5x25 selftap 00625004525
Bone screw 4.5x50 selftap 00625004550
Bone screw 6.5x15 selftap 00625006515
Bone screw 6.5x20 selftap 00625006520
Bone screw 6.5x Terminated |
LPH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 17 consists of all product under product code: LPH and same usage:
Item no:
625004515 BONE SCREW 4.5X15 SELF-TA
625004520 BONE SCREW 4.5X20 SELF-TA
625004525 BONE SCREW 4.5X25 SELF-TA
62500 Terminated |
LPH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 25 consists of all product under product code: LPH and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
2348005 Terminated |
LPH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 47 consists of all product under product code: LPH and same usage:
Item no:
611004022 MODULAR CUP 10 DEGREE LIN
611004428 MODULAR CUP 10 DEGREE LIN
611004628 MODULAR CUP 10 DEGREE LIN
611004 Terminated |
LPH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 63 consists of all product under product code: LPH and same usage:
Item no:
620004020 TRILOGY ACET SHELL 40MM O
620004220 TRILOGY ACET SHELL 42MM O
620004420 TRILOGY ACET SHELL 44MM O
6200046 Terminated |
LPH | None listed |
| Dec 24, 2014 | Zimmer Manufacturing B.V. Trilogy Fiber Metal Acetabular Shell Size 54 mm OD
The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision sur Terminated |
LPH | None listed |
| Dec 17, 2014 | Zimmer Manufacturing B.V. Bone Screw, self-tapping
The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional f Terminated |
LPH | None listed |
| Jul 10, 2014 | Zimmer Manufacturing B.V. Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary intern Terminated |
HWC | None listed |
| Feb 20, 2014 | Zimmer, Inc. TRILOGY ACET SHELL 36MM O
TRILOGY ACET SHELL 38MM O
TRILOGY ACET SHELL 40MM O
TRILOGY ACET SHELL 42MM O
TRILOGY ACET SHELL 44MM O
TRILOGY ACET SHELL 46MM O
TRILOGY ACET SHELL 48MM O
TRILOGY ACET SHELL Terminated |
LPH | None listed |
| Feb 4, 2013 | Zimmer, Inc. Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM.
The Trilogy Acetabular System is indicated fo Terminated |
LPH | None listed |
| Feb 4, 2013 | Zimmer, Inc. Trilogy F/M Acetabular Shell with Uni-Hole.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | None listed |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shell Spiked.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | None listed |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shell with Cluster Holes.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | None listed |
| Feb 4, 2013 | Zimmer, Inc. Trilogy Acetabular Shells with Holes.
The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Terminated |
LPH | None listed |
| Mar 19, 2008 | Zimmer Inc. Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, Terminated |
LPH | None listed |
| Aug 3, 2006 | Zimmer Inc. Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6250-65-20 (00625006520). Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.