Atlas FDA

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM

FDA 510(k) clearance K060704 · decided 2006-05-19

Clearance details

K-number
K060704
Device name
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2006-03-16
Decision date
2006-05-19
Days to decision
64 days
Clearance type
Special
Product code
PHX
Device class
2
Regulation number
888.3660
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
Veritas Shoulder System (K260556)Restor3D2026-07-01
Augment Off-Axis Instrument System (K261683)Zimmer, Inc.2026-06-16
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (K260102)Stryker Corporation (Tornier, Inc.)2026-06-12
MSS - Humeral reverse liners extension (K261016)Medacta International, SA2026-06-10
Veritas Reverse Total Shoulder System (K253992)Restor3D2026-05-07
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404)Biomet Orthopedics2026-04-15
Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
InSet Reverse Total Shoulder System (K254128)Shoulder Innovations, Inc.2026-04-13
Blueprint Patient-Specific Instrumentation (K253674)Stryker Corporation (Tornier, S.A.S.)2026-04-03
INHANCE™ Reverse Shoulder System (K253624)Depuy Ireland UC2026-03-11
MSS - Monobloc stem (K250644)Medacta International S.A.2026-02-03
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352)Lima Corporate S.P.A.2026-01-22

Recalls involving this device

RecordFirmDate
Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique recall (Z-2212-2012)Zimmer, Inc.2012-08-16
00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle Per surgical t recall (Z-2213-2012)Zimmer, Inc.2012-08-16
00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical tech recall (Z-2214-2012)Zimmer, Inc.2012-08-16
00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical recall (Z-2215-2012)Zimmer, Inc.2012-08-16
ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of th recall (Z-0570-2011)Zimmer Inc.2010-12-09
ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of t recall (Z-0571-2011)Zimmer Inc.2010-12-09
TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Meta recall (Z-0573-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, R recall (Z-0574-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97 recall (Z-0575-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309 recall (Z-0576-2011)Zimmer Inc.2010-12-09

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