510(k) Report

510(k) · Cleared

Cleared

GKS Prime Flex CR Total Knee System

K122975510(k) TraditionalCleared Dec 20, 201285-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Permedica · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 20, 2012 as substantially equivalent to K023211 (Zimmer, Inc., 2002) and 6 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1994.

Decided
Dec 20, 2012
Review
85 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
7

Its longest line of descent runs back 8 generations to K941847 (1994). 90 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2007: 4 other ancestors2005: 2 other ancestors2002: 6 other ancestors1997: 6 other ancestors1995: 6 other ancestors2008: 1 other ancestor2006: 2 other ancestors2003: 6 other ancestors1999: 3 other ancestors1996: 9 other ancestors2004: 3 other ancestors2001: 6 other ancestors2000: 6 other ancestors1998: 5 other ancestors1994: 5 other ancestors1993: 2 other ancestors1992: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1987: 2 other ancestors1984: 1 other ancestor1985: 1 other ancestorK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK070981 · Search Evolution (LC) Total Knee System (Plasmapore) · Aesculap Implant Systems, Inc. · 2007K081023 · Evolis Total Knee System · Medacta International S.A. · 2008 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 13 other ancestors3 generations back: 7 other ancestors4 generations back: 17 other ancestors5 generations back: 17 other ancestors6 generations back: 13 other ancestors7 generations back: 8 other ancestors K081023 · Evolis Total Knee System · Medacta International S.A. · 2008 · recalledK070981 · Search Evolution (LC) Total Knee System (Plasmapore) · Aesculap Implant Systems, Inc. · 2007K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−50
  1. Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. 2 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  8. 1 generation backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
  9. This deviceK122975 GKS Prime Flex CR Total Knee SystemPermedica · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−7K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−6K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−5K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−4K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−3K042344Excia Total Hip SystemAesculap, Inc.200510
−2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
−1K081023Evolis Total Knee SystemMedacta International S.A.20081
0 (this device)K122975GKS Prime Flex CR Total Knee SystemPermedica2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198720
199010
199110
199220
199320
199450
199560
199690
199760
199850
199930
200060
200160
200260
200360
200430
200520
200620
200740
200810
201110
FIG. 1 — Lineage of K122975, 1994–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components
Summary page 1
…ion Name: Knee joint, patellofemorotibial metalI/polyme r/metal Semi-constrained cemented prosthesis, 21 CFR 888.3560 Main Predicate: NexGen® Complete Knee Solution K02321 1 NexGen® Complete Knee Solution Cruciate Retaining (CR) - Flex (Zimmer) K072281 NexGen® ProlongM All Poly Patella (Zimmer) K933785…
Zimmer, Inc.20026
*K072281Nexgen Prolong All-Poly Patella
Summary page 1
…ined cemented prosthesis, 21 CFR 888.3560 Main Predicate: NexGen® Complete Knee Solution K02321 1 NexGen® Complete Knee Solution Cruciate Retaining (CR) - Flex (Zimmer) K072281 NexGen® ProlongM All Poly Patella (Zimmer) K933785 NexGen® Complete Knee Solution (Zimmer) Other Predicates K081 023 Evolis Total…
Zimmer, Inc.2007—
*K933785Next Generation Knee System
Summary page 1
…dicate: NexGen® Complete Knee Solution K02321 1 NexGen® Complete Knee Solution Cruciate Retaining (CR) - Flex (Zimmer) K072281 NexGen® ProlongM All Poly Patella (Zimmer) K933785 NexGen® Complete Knee Solution (Zimmer) Other Predicates K081 023 Evolis Total Knee System (Medlacta International) K041825 Genes…
Zimmer, Inc.199583
*K081023Evolis Total Knee System
Summary page 1
…Knee Solution Cruciate Retaining (CR) - Flex (Zimmer) K072281 NexGen® ProlongM All Poly Patella (Zimmer) K933785 NexGen® Complete Knee Solution (Zimmer) Other Predicates K081 023 Evolis Total Knee System (Medlacta International) K041825 Genesis 11Deep Flexion Cruciate Retaining Articular Insert (Smith and N…
Medacta International S.A.20081
*K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert
Summary page 1
…81 NexGen® ProlongM All Poly Patella (Zimmer) K933785 NexGen® Complete Knee Solution (Zimmer) Other Predicates K081 023 Evolis Total Knee System (Medlacta International) K041825 Genesis 11Deep Flexion Cruciate Retaining Articular Insert (Smith and Nephew) Ki110950 Consensus Knee System, Consensus Orthopedi…
Smith & Nephew, Inc.2005—
*K110950Consensus Knee System
Summary page 1
…mmer) Other Predicates K081 023 Evolis Total Knee System (Medlacta International) K041825 Genesis 11Deep Flexion Cruciate Retaining Articular Insert (Smith and Nephew) Ki110950 Consensus Knee System, Consensus Orthopedics (based on K932837) K971189 P.F.C Sigma Knee System (Johnson & Johnson Professional,…
Consensus Orthopedics, Inc.2011—
*K971189P.F.C. Sigma Knee System (Size 1.5)
Summary page 1
…rnational) K041825 Genesis 11Deep Flexion Cruciate Retaining Articular Insert (Smith and Nephew) Ki110950 Consensus Knee System, Consensus Orthopedics (based on K932837) K971189 P.F.C Sigma Knee System (Johnson & Johnson Professional, Inc., now DePuy Orthopedics) GKS Prime Flex CR 510(k)…
Johnson & Johnson Professionals, Inc.1997—

Also cleared against K023211: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
  • 37 of the 89 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K023211.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

G.K.S. PRIME FLEX CR is indicated for use in patients with severely painful and disabled joints due to:

* Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis

* Failed osteotomies

" Avascular necrosis of femoral condyle

" Post traumatic loss of joint configuration

* Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability

* Primary implantation failure if there is sufficient bone

The device is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K023211

11 other devices cite the same predicate.

  • K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 20182 recalls
  • K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd. · 2017
  • K140222Saiph Knee SystemMatortho · 2014
  • K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012
  • K120313Neo CR Knee SystemPipeline Orthopedics · 2012
  • K113369Zimmer Persona Knee SystemZimmer, Inc. · 201239 recalls

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K122975 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122975: GKS Prime Flex CR Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122975

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026