510(k) Report

510(k) · Cleared

Recalled · 2009

Stelkast Unicondylar Knee System

K032824510(k) TraditionalCleared Nov 13, 200364-day reviewClass II21 CFR 888.3520Recalls 1

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

Stelkast Company · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Nov 13, 2003 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 62 later devices descend from it. It has been recalled once.

Decided
Nov 13, 2003
Review
64 days
Class
Class II
Product code
HSX
Recalls
1
Predicates
0

62 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2024: 6 descendants cleared2006: 1 descendant cleared2023: 5 descendants cleared2008: 3 descendants cleared2007: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 4 descendants cleared2015: 2 descendants cleared2019: 7 descendants cleared2020: 6 descendants cleared2021: 5 descendants cleared2026: 7 descendants cleared2025: 4 descendants cleared2018: 2 descendants cleared2022: 3 descendants cleared200020052010201520202025
  1. This deviceK032824 Stelkast Unicondylar Knee SystemStelkast Company · 2003
  2. Descendant · cites it directly · 58 of its ownK060017 Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2006
  3. Descendant · 2 generations on · 57 of its ownK073248 Modification to:Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2007
  4. Descendant · 2 generations on · 56 of its ownK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. Descendant · 3 generations on · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
  6. Descendant · 4 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 32009: 12013: 22014: 12015: 22016: 12017: 42018: 22019: 72020: 62021: 52022: 32023: 52024: 62025: 42026: 7
2005high 7 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 62 · See all
  • K060017Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2006 · cites it directly58descendants
  • K073248Modification to:Mako Surgical Unicondylar Knee SystemMako Surgical Corp. · 2007 · 2 generations on57descendants
  • K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008 · 2 generations on56descendants
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · 3 generations on51descendants
  • K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 4 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032824Stelkast Unicondylar Knee SystemStelkast Company2003—
+1K060017Mako Surgical Unicondylar Knee SystemMako Surgical Corp.2006—
+2K073248Modification to:Mako Surgical Unicondylar Knee SystemMako Surgical Corp.2007—
+2K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
+3K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation20082
+4K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200830
200910
201320
201410
201520
201610
201740
201820
201970
202060
202150
202230
202350
202460
202540
202670
FIG. 1 — Lineage of K032824, 2003–2026Source: 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 HSX? 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 HSX device

  1. #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K060017Mako Surgical Unicondylar Knee SystemMako Surgical Corp.200658
K050373Unicap Unicompartmental Knee Resurfacing ProsthesisArthrosurface, Inc.20052
K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240

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

Recalls of this device

DateClassRecallRoot causeReason
May 5, 2009Not classifiedZ-0371-2010Nonconforming Material/Componentincorrect size markings on component

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K060017 (Mako Surgical Corp., 2006) has gone furthest, with 58 descendants of its own.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSX

4in 2025

2007: 62008: 42009: 22010: 32011: 12012: 52013: 22015: 12016: 32017: 52018: 22019: 72020: 42021: 72022: 22023: 12024: 42025: 42026 (partial year): 2
2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007: 33 days median2008: 102 days median2010: 74 days median2012: 88 days median2016: 147 days median2017: 160 days median2019: 90 days median2020: 40 days median2021: 81 days median2024: 133 days median2025: 59 days median
2007high 160 (2017) · low 33 (2007)2026

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

Recalls per year · HSX

2in 2020

2009: 492013: 12016: 12017: 42020: 2
2007high 49 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSX

175in 2025

2007: 62008: 42009: 212010: 582011: 1142012: 832013: 792014: 662015: 572016: 1072017: 1132018: 1592019: 1772020: 2732021: 2402022: 2572023: 2312024: 1722025: 175
2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, 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
200763306
2008410204
20092—4921
2010374058
20111—0114
2012588083
20132—179
20140—066
20151—057
201631471107
201751604113
20182—0159
20197900177
20204402273
20217810240
20222—0257
20231—0231
202441330172
20254590175
20262—0—

What is it indicated for?

1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic).

2. Revision of a failed unicompartmental knee implant or other procedure.

3. Alternative to tibial osteotomy in patients with unicompartmental arthritis.

Indications for use as stated in the FDA 510(k) statement.

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 HSX

The HSX category page

  • K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
  • K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
  • K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
  • K251834Persona Partial KneeZimmer Biomet · 2025
  • K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025

https://510kreport.com/device/K032824 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032824: Stelkast Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032824

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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