Atlas FDA

BETA HIP PROSTHESIS

FDA 510(k) clearance K953337 · decided 1996-01-22

Clearance details

K-number
K953337
Device name
BETA HIP PROSTHESIS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1995-07-17
Decision date
1996-01-22
Days to decision
189 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
Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, por recall (Z-2577-2017)Zimmer Biomet, Inc.2017-03-20
Por fullct fem st 16x200mm, Sterile, recall (Z-2578-2017)Zimmer Biomet, Inc.2017-03-20
Por fullct fem st 17x200mm, Sterile, recall (Z-2579-2017)Zimmer Biomet, Inc.2017-03-20
Por fullct fem st 18x200mm, Sterile, recall (Z-2580-2017)Zimmer Biomet, Inc.2017-03-20
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specif recall (Z-2581-2017)Zimmer Biomet, Inc.2017-03-20
Product 29 consists of all product under product code: LPHand same usage: Item no: 3290260 recall (Z-1127-2016)Zimmer Manufacturing B.V.2016-03-12
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INC recall (Z-0849-2016)Zimmer Biomet, Inc.2016-02-22
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) recall (Z-1031-2014)Zimmer, Inc.2014-02-20
6 DEGREE COCR FEM HEAD 36 recall (Z-1034-2014)Zimmer, Inc.2014-02-20
Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200M recall (Z-0070-2014)Zimmer, Inc.2013-10-25
VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO recall (Z-2290-2010)Zimmer Inc.2010-08-26
VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO recall (Z-2291-2010)Zimmer Inc.2010-08-26
Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile recall (Z-0198-2010)Zimmer Inc.2009-11-13
Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Pro recall (Z-1066-05)Zimmer Inc.2005-08-03

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