Atlas FDA

TRILOGY ACETABULAR SYSTEM

FDA 510(k) clearance K934765 · decided 1994-04-29

Clearance details

K-number
K934765
Device name
TRILOGY ACETABULAR SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1993-10-05
Decision date
1994-04-29
Days to decision
206 days
Clearance type
Traditional
Product code
LPH
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
TRIVANCE™ Hip Stem (K254043)Globus Medical, Inc.2026-08-04
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (K261624)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-07-10
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192)Nextstep Arthopedix, LLC2026-06-05
Taperloc® Complete Hip Stem (K251270)Biomet, Inc.2026-05-19
G7® Revision Acetabular System (K252623)Zimmer, Inc.2026-02-04
Mpact 3D Metal Implants Extension – DMLS Technology (K251043)Medacta International S.A.2026-01-28
Velora Acetabular System (K252067)Restor3D, Inc.2025-12-05
TaperSet™ Hip System (K252846)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
EMPOWR Acetabular® Liner Extension (K251833)Encore Medical L.P.2025-11-12
ArTT Augments and Buttresses and Bone Screws (K251718)Lima Corporate S.P.A.2025-08-29
Stryker and Serf hip devices (K250989)Howmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
ONVOY™ Acetabular System (K243456)Globus Medical, Inc.2025-06-06

Recalls involving this device

RecordFirmDate
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 se recall (Z-1684-2016)Zimmer Manufacturing B.V.2016-05-16
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004 recall (Z-1115-2016)Zimmer Manufacturing B.V.2016-03-12
Product 25 consists of all product under product code: LPH and same usage: Item no: 234703 recall (Z-1123-2016)Zimmer Manufacturing B.V.2016-03-12
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004 recall (Z-1145-2016)Zimmer Manufacturing B.V.2016-03-12
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004 recall (Z-1161-2016)Zimmer Manufacturing B.V.2016-03-12
Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indica recall (Z-0875-2015)Zimmer Manufacturing B.V.2014-12-24
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, mu recall (Z-0824-2015)Zimmer Manufacturing B.V.2014-12-17
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4M recall (Z-2032-2014)Zimmer Manufacturing B.V.2014-07-10
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET recall (Z-1024-2014)Zimmer, Inc.2014-02-20
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50M recall (Z-0769-2013)Zimmer, Inc.2013-02-04
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for recall (Z-0771-2013)Zimmer, Inc.2013-02-04
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cem recall (Z-0772-2013)Zimmer, Inc.2013-02-04
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated fo recall (Z-0773-2013)Zimmer, Inc.2013-02-04
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for eithe recall (Z-0775-2013)Zimmer, Inc.2013-02-04
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI- recall (Z-0620-2008)Zimmer Inc.2008-03-19
Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, ster recall (Z-1344-06)Zimmer Inc.2006-08-03

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13