Atlas FDA

MODULAR REACH HIP

FDA 510(k) clearance K994038 · decided 1999-12-22

Clearance details

K-number
K994038
Device name
MODULAR REACH HIP
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1999-11-29
Decision date
1999-12-22
Days to decision
23 days
Clearance type
Special
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16