Atlas FDA

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS

FDA 510(k) clearance K101730 · decided 2010-12-03

Clearance details

K-number
K101730
Device name
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2010-06-18
Decision date
2010-12-03
Days to decision
168 days
Clearance type
Traditional
Product code
KWZ
Device class
2
Regulation number
888.3310
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.

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SMITH & NEPHEW R3 CONSTRAINED LINERS (K122139)Smith & Nephew, Inc.2012-10-16
SMITH & NEPHEW RJ CONSTRAINED LINERS (K111635)Smith & Nephew, Inc.2011-09-09
R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566)Smith & Nephew, Inc.2009-03-03
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (K072121)Zimmer, Inc.2008-01-07
DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059)DePuy Orthopaedics, Inc.2007-11-09
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS (K071676)Exactech, Inc.2007-07-19
TRILOGY LONGEVITY CONSTRAINED LINER (K071718)Zimmer, Inc.2007-07-13

Recalls involving this device

No recalls on record reference this clearance.

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