510(k) Report

510(k) · Cleared

Recalled · 2008

Stelkast Proven Cemented, Semi-Constrained Total Knee System

K980276510(k) TraditionalCleared Apr 24, 199888-day reviewClass II21 CFR 888.3560Recalls 1

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

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

Cleared on Apr 24, 1998 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled once.

Decided
Apr 24, 1998
Review
88 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
0

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980276 Stelkast Proven Cemented, Semi-Constrained Total Knee SystemStelkast Company · 1998
  2. Descendant · cites it directly · 4 of its ownK122883 Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex…Stelkast Company · 2013 · Recalled
  3. Descendant · cites it directly · 3 of its ownK162222 GENflex2 Total Knee SystemStelkast, Inc. · 2016
  4. Descendant · cites it directly · 2 of its ownK173875 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018
  5. Descendant · cites it directly · 1 of its ownK240669 ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. · 2024
  6. Descendant · 2 generations on · 0 of its ownK262251 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC…Globus Medical, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12013: 12016: 12018: 12024: 12026: 1
2003high 1 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 2013 · cites it directly4descendants
  • K162222GENflex2 Total Knee SystemStelkast, Inc. · 2016 · cites it directly3descendants
  • K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018 · cites it directly2descendants
  • K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. · 2024 · cites it directly1descendant
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980276Stelkast Proven Cemented, Semi-Constrained Total Knee SystemStelkast Company1998—
+1K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee…Stelkast Company20131
+1K162222GENflex2 Total Knee SystemStelkast, Inc.2016—
+1K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.2018—
+1K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.2024—
+2K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial…Globus Medical, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201310
201610
201810
202410
202610
FIG. 1 — Lineage of K980276, 1998–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company20134
K162222GENflex2 Total Knee SystemStelkast, Inc.20163
K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182
K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241
K031901Proven Revision Femoral and Proven Revision Tibial InsertStelkast Company20030

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 3, 2008Not classifiedZ-0308-2009Employee errorFive (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K122883 (Stelkast Company, 2013) has gone furthest, with 4 descendants of its own.

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.

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?

1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis

and/or post-traumatic degenerative problems.

2. Revision of failed previous reconstructions where sufficient bone stock and soft

integrity are present.

3. For cemented use only.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Stelkast Company

43 FDA decisions under this applicant name. See the company

  • K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 20131 recall
  • K122773Cross-Over Acetabular Shell & LinerStelkast Company · 20121 recall
  • P040051/S002Stelkast Surpass Acetabular SystemStelkast Company · 2011
  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011
  • P040051/S001Stelkast Surpass Acetabular SystemStelkast Company · 2009

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/K980276 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980276: Stelkast Proven Cemented, Semi-Constrained Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980276

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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