Atlas FDA

ZIMMER TRABECULAR METAL HUMERAL STEM

FDA 510(k) clearance K041549 · decided 2004-09-01

Clearance details

K-number
K041549
Device name
ZIMMER TRABECULAR METAL HUMERAL STEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2004-06-09
Decision date
2004-09-01
Days to decision
84 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 recall (Z-1092-2014)Zimmer, Inc.2014-02-26
ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of th recall (Z-0570-2011)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
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 4 recall (Z-0177-2010)Zimmer Inc.2009-11-12
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 4 recall (Z-0178-2010)Zimmer Inc.2009-11-12

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