Atlas FDA

INSALL/BURSTEIN* II MODULAR TOTAL KNEE

FDA 510(k) clearance K872379 · decided 1987-10-28

Clearance details

K-number
K872379
Device name
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1987-06-19
Decision date
1987-10-28
Days to decision
131 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
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 recall (Z-0466-2023)Zimmer, Inc.2022-12-09
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 recall (Z-0467-2023)Zimmer, Inc.2022-12-09
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 recall (Z-0468-2023)Zimmer, Inc.2022-12-09
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 recall (Z-0469-2023)Zimmer, Inc.2022-12-09
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 recall (Z-0470-2023)Zimmer, Inc.2022-12-09
NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 recall (Z-0471-2023)Zimmer, Inc.2022-12-09
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007 recall (Z-1133-2016)Zimmer Manufacturing B.V.2016-03-12
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603 recall (Z-1149-2016)Zimmer Manufacturing B.V.2016-03-12
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 a recall (Z-1021-2014)Zimmer, Inc.2014-02-20
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 CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is recall (Z-0437-2013)Zimmer, Inc.2012-11-26

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