Atlas FDA

NEXT GENERATION KNEE SYSTEM

FDA 510(k) clearance K933785 · decided 1995-01-30

Clearance details

K-number
K933785
Device name
NEXT GENERATION KNEE SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent for Some Indications
Date received
1993-08-04
Decision date
1995-01-30
Days to decision
544 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
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
Freedom Total Knee System (E-Poly Tibial Liners) (K261563)Maxx Orthopedics, Inc.2026-08-07
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251)Globus Medical, Inc.2026-07-31
Klassic Infection Spacer System (K261734)Total Joint Orthopedics, Inc.2026-07-23
ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458)DePuy Ireland UC2026-06-25
NovoKnee (SteriKnee) (K261032)NovoSource2026-04-27
Materialise TKA Guide System (K253793)Materialise NV2026-01-06
EMPOWR Knee (K252974)Encore Medical L.P.2025-12-19
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197)Depuy Ireland UC2025-11-19
Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
Freedom® Total Knee System – Titan PCK Components (K253144)Maxx Orthopedics, Inc.2025-10-22
Stem Extension Line (U2 Total Knee System—PSA Type) (K252725)United Orthopedic Corporation2025-09-25
Materialise TKA Guide System (K251554)Materialise NV2025-07-14

Recalls involving this device

RecordFirmDate
Product 49 consists of all product under product code: JWH and same usage: Item no: 597206 recall (Z-1147-2016)Zimmer Manufacturing B.V.2016-03-12
Product 53 consists of all product under: product code: JWH and same usage: Item no: 59700 recall (Z-1151-2016)Zimmer Manufacturing B.V.2016-03-12
Product 61 consists of all product under product code: JWH and same usage: Item no: 598003 recall (Z-1159-2016)Zimmer Manufacturing B.V.2016-03-12
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee recall (Z-0835-2016)Zimmer Biomet, Inc.2016-02-22
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 N recall (Z-0590-2016)Zimmer Manufacturing B.V.2016-01-05
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM recall (Z-2552-2014)Zimmer, Inc.2014-08-26
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP recall (Z-1023-2014)Zimmer, Inc.2014-02-20
NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates a recall (Z-0480-2014)Zimmer, Inc.2013-12-11
00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro recall (Z-1547-2012)Zimmer Inc.2012-05-14
00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro recall (Z-1548-2012)Zimmer Inc.2012-05-14
00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro recall (Z-1549-2012)Zimmer Inc.2012-05-14
00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro recall (Z-1550-2012)Zimmer Inc.2012-05-14
00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro recall (Z-1551-2012)Zimmer Inc.2012-05-14
00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micr recall (Z-1552-2012)Zimmer Inc.2012-05-14
90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro recall (Z-1553-2012)Zimmer Inc.2012-05-14
00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Mic recall (Z-1554-2012)Zimmer Inc.2012-05-14
90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro recall (Z-1555-2012)Zimmer Inc.2012-05-14
90-5952-020-20, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Mi recall (Z-1556-2012)Zimmer Inc.2012-05-14
00-5970-020-09, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Si recall (Z-1557-2012)Zimmer Inc.2012-05-14
00-5970-020-10, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Si recall (Z-1558-2012)Zimmer Inc.2012-05-14
00-5970-020-12, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Si recall (Z-1559-2012)Zimmer Inc.2012-05-14
00-5970-020-14, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Si recall (Z-1560-2012)Zimmer Inc.2012-05-14
00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Si recall (Z-1561-2012)Zimmer Inc.2012-05-14
00-5970-020-20 NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface recall (Z-1562-2012)Zimmer Inc.2012-05-14
90-5970-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1563-2012)Zimmer Inc.2012-05-14
90-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height , U recall (Z-1564-2012)Zimmer Inc.2012-05-14
90-5970-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1565-2012)Zimmer Inc.2012-05-14
90-5970-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1566-2012)Zimmer Inc.2012-05-14
90-5970-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1567-2012)Zimmer Inc.2012-05-14
90-5970-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1568-2012)Zimmer Inc.2012-05-14
00-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1569-2012)Zimmer Inc.2012-05-14
00-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1570-2012)Zimmer Inc.2012-05-14
00-5972-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1571-2012)Zimmer Inc.2012-05-14
00-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1572-2012)Zimmer Inc.2012-05-14
00-5972-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1573-2012)Zimmer Inc.2012-05-14
00-5972-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1574-2012)Zimmer Inc.2012-05-14
00-5976-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1575-2012)Zimmer Inc.2012-05-14
00-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1576-2012)Zimmer Inc.2012-05-14
00-5976-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1577-2012)Zimmer Inc.2012-05-14
00-5976-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surfac recall (Z-1578-2012)Zimmer Inc.2012-05-14
00-5952-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1579-2012)Zimmer Inc.2012-05-14
00-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruci recall (Z-1580-2012)Zimmer Inc.2012-05-14
REF 00-5952-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1581-2012)Zimmer Inc.2012-05-14
REF 00-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1582-2012)Zimmer Inc.2012-05-14
REF 00-5952-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1583-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1584-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1585-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1586-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1587-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1588-2012)Zimmer Inc.2012-05-14

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