Atlas FDA

MG II POROUS TOTAL KNEE SYSTEM

FDA 510(k) clearance K892800 · decided 1989-08-03

Clearance details

K-number
K892800
Device name
MG II POROUS TOTAL KNEE SYSTEM
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1989-04-17
Decision date
1989-08-03
Days to decision
108 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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Devices cleared under the same product code - the starting set for predicate research.

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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
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NovoKnee (SteriKnee) (K261032)NovoSource2026-04-27
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Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
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Recalls involving this device

RecordFirmDate
Product 26 consists of all product under product code: JWH and same usage: Item no: 234703 recall (Z-1124-2016)Zimmer Manufacturing B.V.2016-03-12
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001 recall (Z-1132-2016)Zimmer Manufacturing B.V.2016-03-12
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007 recall (Z-1143-2016)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
FEM HD ION (various sizes) recall (Z-1037-2014)Zimmer, Inc.2014-02-20
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
REF 90-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1589-2012)Zimmer Inc.2012-05-14
REF 90-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1590-2012)Zimmer Inc.2012-05-14
REF 00-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1591-2012)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