510(k) Report

510(k) · Cleared

Cleared

Unicondylar Interpositional Spacer

K003269510(k) TraditionalCleared Jan 4, 200178-day reviewClass II21 CFR 888.3590

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

Sulzer Orthopedics, Inc. · HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Cleared on Jan 4, 2001 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided
Jan 4, 2001
Review
78 days
Class
Class II
Product code
HSH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2006: 3 descendants cleared2008: 2 descendants cleared2005: 1 descendant cleared2007: 3 descendants cleared2009: 2 descendants cleared2011: 3 descendants cleared2017: 1 descendant cleared2012: 6 descendants cleared2010: 1 descendant cleared2014: 6 descendants cleared2020: 3 descendants cleared2013: 5 descendants cleared2019: 4 descendants cleared2021: 9 descendants cleared2016: 5 descendants cleared2026: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2023: 5 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003269 Unicondylar Interpositional SpacerSulzer Orthopedics, Inc. · 2001
  2. Descendant · cites it directly · 65 of its ownK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
  3. Descendant · 2 generations on · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
  5. Descendant · 3 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
  6. Descendant · 4 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 32007: 32008: 22009: 22010: 12011: 32012: 62013: 52014: 62015: 12016: 52017: 12018: 12019: 42020: 32021: 92022: 22023: 52025: 12026: 1
2003high 9 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 66 · See all
  • K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003 · cites it directly65descendants
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · 2 generations on62descendants
  • K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · 2 generations on43descendants
  • K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 3 generations on41descendants
  • K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 4 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003269Unicondylar Interpositional SpacerSulzer Orthopedics, Inc.2001—
+1K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc.2003—
+2K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+2K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.2006—
+3K094050Itotal CR Knee Replacement SystemConformis, Inc.2010—
+4K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200630
200730
200820
200920
201010
201130
201260
201350
201460
201510
201650
201710
201810
201940
202030
202190
202220
202350
202510
202610
FIG. 1 — Lineage of K003269, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc.200365
K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062…Advanced Bio-Surfaces, Inc.20061
K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc.20080

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, K033242 (Imaging Therapeutics, Inc., 2003) has gone furthest, with 65 descendants of its own.

How does its category compare?

All HSH devices

HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSH

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSH

Too few HSH 510(k)s in any year since 2007 to give a median.

Recalls per year · HSH

No recall names HSH since 2007.

Adverse event reports per year · HSH

1in 2022

2007: 6482008: 8792009: 1,1152010: 5432011: 222012: 792013: 372014: 162015: 182017: 32018: 32022: 1
2007high 1,115 (2009) · low 0 (2016)2025

MAUDE reports naming product code HSH, 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
20070—0648
20081—0879
20090—01,115
20100—0543
20110—022
20120—079
20130—037
20140—016
20150—018
20160—00
20170—03
20180—03
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Sulzer Orthopedics, Inc.

45 FDA decisions under this applicant name. See the company

  • K022985Ascendent Acetabular SystemSulzer Orthopedics, Inc. · 20021 recall
  • K021578Natural-Knee II System Cocr Tibial BaseplateSulzer Orthopedics, Inc. · 2002
  • K020713MS-30 Lateral Femoral StemSulzer Orthopedics, Inc. · 20021 recall
  • K013935Allofit Acetabular System 32MM Alpha Durasul InsertsSulzer Orthopedics, Inc. · 2001
  • K013031Most Options SystemSulzer Orthopedics, Inc. · 20013 recalls

Recent decisions in HSH

The HSH category page

  • K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc. · 2008
  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 2006
  • K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
  • K022779Oti Unicondular Interpositional SpacerOsteoimplant Technology, Inc. · 2002

https://510kreport.com/device/K003269 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003269: Unicondylar Interpositional Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003269

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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