510(k) Report

510(k) · Cleared

Cleared

Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm

K130084510(k) TraditionalCleared May 3, 2013109-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

Tgm Medical, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 3, 2013 as substantially equivalent to K953443 (U.S. Medical Products, Inc., 1996) and 2 other predicates after a 109-day review. Its family tree reaches back 7 generations to 1995.

Decided
May 3, 2013
Review
109 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K933785 (1995). 22 ancestors in all, the oldest K884796 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor1996: 2 other ancestors2000: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2007: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor2005: 1 other ancestor1999: 1 other ancestorK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalledK110950 · Consensus Knee System · Consensus Orthopedics, Inc. · 2011K112285 · Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate... · Tgm Medical, Inc. · 20111985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 4 other ancestors K112285 · Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate... · Tgm Medical, Inc. · 2011K110950 · Consensus Knee System · Consensus Orthopedics, Inc. · 2011K073286 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2008 · recalledK070214 · Gender Solutions Natural-Knee Flex System · Zimmer, Inc. · 2007 · recalledK060370 · Nexgen Knee Gender Solutions Female (GSF) Femoral Components · Zimmer, Inc. · 2006 · recalledK023211 · Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components · Zimmer, Inc. · 2002 · recalledK933785 · Next Generation Knee System · Zimmer, Inc. · 1995 · recalled−50
  1. Root · 7 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
  2. 6 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
  3. 5 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
  4. 4 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
  5. 3 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
  6. 2 generations backK110950 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
  7. 1 generation backK112285 Milestone Knee System, Femoral Component, Posterior Stablized…Tgm Medical, Inc. · 2011
  8. This deviceK130084 Milestone Revision Knee System (MRKS) - Femoral Component, Tibial…Tgm Medical, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K933785Next Generation Knee SystemZimmer, Inc.199583
−6K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20026
−5K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200617
−4K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200763
−3K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20085
−2K110950Consensus Knee SystemConsensus Orthopedics, Inc.2011—
−1K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP…Tgm Medical, Inc.2011—
0 (this device)K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate…Tgm Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199410
199510
199620
199710
199910
200020
200120
200510
200710
201010
FIG. 1 — Lineage of K130084, 1995–2013Source: 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? (3)

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
*K953443Consensus PCL Subsituting Tibial Insert
Summary page 2
…previously cleared Consensus Revision Knee System (CRKS) components (K 100542) and the Consensus Knee System (CKS) ultracongruent (i.e. PCL substituting) tibial inserts (K953443) to TOM Medical for use as the MILESTONE Revision Knee System (MRKS). These predicate knee system components are identical to the…
U.S. Medical Products, Inc.1996—
*K100542Consensus Revision Knee System
Summary page 2
…hnological Characteristics/Substantial Equivalence: Co nsensus Orthopedics, Inc. (COI) licensed the previously cleared Consensus Revision Knee System (CRKS) components (K 100542) and the Consensus Knee System (CKS) ultracongruent (i.e. PCL substituting) tibial inserts (K953443) to TOM Medical for use as th…
Consensus Orthopedics, Inc.2010—
*K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…
Summary page 3
…uting Tibia) U.S. Medical Products, Inc. .04/26/1996* Insert K100542 Consensus Revision Knee System Consensus Orthopedics, Inc. 06/24/2010 KI112285 Milestone Knee System TOM Medical, Inc. 11/04/2011 Notes: *Cleared prior to the purcha…
Tgm Medical, Inc.2011—

Also cleared against K953443: 2 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 3 companies; a new generation was cleared every 1.5 years on median.
  • 10 of the 22 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K953443.

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. 2013, 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?

A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy). C. Failed osteotomy or unicompartmental replacements. D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock…

Read the full statement (105 words)

A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.

B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy).

C. Failed osteotomy or unicompartmental replacements.

D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

F. Moderate valgus, varus, or flexion deformities.

All MRKS femoral components and tibial baseplates are intended for CEMENTED USE ONLY. All MRKS stems are intended for UNCEMENTED USE.

Indications for use as stated in the FDA summary.

Also cleared against K953443

2 other devices cite the same predicate.

  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014

More from Tgm Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
  • K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012
  • K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 2012
  • K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert /…Tgm Medical, Inc. · 2011

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/K130084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130084: Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130084

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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