510(k) Report

510(k) · Cleared

Cleared

Continuum Knee System (CKS)-Modification

K903286510(k) TraditionalCleared Oct 12, 199088-day reviewClass II21 CFR 888.3520

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

Techmedica, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Oct 12, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Oct 12, 1990
Review
88 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK903286 Continuum Knee System (CKS)-ModificationTechmedica, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK964951 Kinemax Plus Tibial SpacersHowmedica Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K964951Kinemax Plus Tibial SpacersHowmedica Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903286Continuum Knee System (CKS)-ModificationTechmedica, Inc.1990—
+1K964951Kinemax Plus Tibial SpacersHowmedica Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K903286, 1990–1997Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964951Kinemax Plus Tibial SpacersHowmedica Corp.19970

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?

  • Of its descendants, K964951 (Howmedica Corp., 1997) has gone furthest, with 0 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—

More from Techmedica, Inc.

31 FDA decisions under this applicant name. See the company

  • K933935CKS Porous Coated Femoral ComponentTechmedica, Inc. · 1994
  • K932017Techmedica Continuum Hip with HA CoatingTechmedica, Inc. · 1994
  • K931929Techmedica Continuum Hip SystemTechmedica, Inc. · 1994
  • K926387Techmedica Standard Cemented Hip SystemTechmedica, Inc. · 1994
  • K925420Techmedica Standard Bipolar SystemTechmedica, Inc. · 1993

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/K903286 · printed Nov 4, 2026

Cite this page

510(k) Report. “K903286: Continuum Knee System (CKS)-Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903286

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026