510(k) Report

510(k) · Cleared

Cleared

Knee Interpositional Mini-Repair System (Kimrs)

K033242510(k) TraditionalCleared Dec 31, 200385-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

Imaging Therapeutics, Inc. · HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Cleared on Dec 31, 2003 as substantially equivalent to K964395 (Hayes Medical, Inc., 1997) and 4 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1992. 65 later devices descend from it.

Decided
Dec 31, 2003
Review
85 days
Class
Class II
Product code
HSH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K911802 (1992). 5 ancestors in all. 65 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor2006: 3 descendants cleared2005: 1 descendant cleared2008: 2 descendants 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 clearedK911802 · Pmi (Patient Matched Implants) Hip Femoral Comp · Biomet, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 10 descendants3 generations forward: 15 descendants4 generations forward: 10 descendants5 generations forward: 8 descendants6 generations forward: 8 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants K911802 · Pmi (Patient Matched Implants) Hip Femoral Comp · Biomet, Inc. · 19920+5
  1. Root · 1 generation backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
  2. This deviceK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
  3. Descendant · cites it directly · 62 of its ownK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
  5. Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
  6. Descendant · 3 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
  7. Descendant · 3 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32007: 32008: 22009: 22010: 12011: 32012: 62013: 52014: 62015: 12016: 52017: 12018: 12019: 42020: 32021: 92022: 22023: 52025: 12026: 1
2005high 9 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 65 · See all
  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · cites it directly62descendants
  • K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · cites it directly43descendants
  • K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
  • K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on40descendants
  • K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911802Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc.1992—
0 (this device)K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc.2003—
+1K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.20053
+1K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.2006—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.2010—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20111
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K033242, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K964395Patient Specific Implant (Psi) Hip Femoral Component
Summary page 2
…Technological Characteristics * Hayes Medical, Patient Specific Implant * Sulzer Orthopedics, Inc., (Centerpulse), (PSI)-Femoral Component (K964395) Unicondylar Interpositional Spacer * Biomet, Patient Matched Implants, (K003269)…
Hayes Medical, Inc.1997—
*K911802Pmi (Patient Matched Implants) Hip Femoral Comp
Summary page 2
…ponent (K964395) Unicondylar Interpositional Spacer * Biomet, Patient Matched Implants, (K003269) Femoral Implants (K911802) * OTI Unicondular Interpositional Spacer · Techmedica, CAD/CAM Custom Hip Sy…
Biomet, Inc.1992—
*K911058Techmedica Cad/Cam Custom Hip
Summary page 2
…lants (K911802) * OTI Unicondular Interpositional Spacer · Techmedica, CAD/CAM Custom Hip System (K022779) (K911058) * McKeever Hemiarthroplasty Prosthesis…
Techmedica, Inc.1993—
*K003269Unicondylar Interpositional Spacer
Summary page 2
…erpulse), (PSI)-Femoral Component (K964395) Unicondylar Interpositional Spacer * Biomet, Patient Matched Implants, (K003269) Femoral Implants (K911802) * OTI Unicondular Interpositional Spacer · Techmedica, CAD/C…
Sulzer Orthopedics, Inc.2001—
*K022779Oti Unicondular Interpositional Spacer
Summary page 2
…Femoral Implants (K911802) * OTI Unicondular Interpositional Spacer · Techmedica, CAD/CAM Custom Hip System (K022779) (K911058) * McKeever Hemiarthroplasty Prosthesis…
Osteoimplant Technology, Inc.2002—
*—McKeever Hemiarthroplasty Prosthesis
Named without a submission number
—

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc.200562
K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc.200643
K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635
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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K043570 (Conformis, Inc., 2005) has gone furthest, with 62 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—

What is it indicated for?

The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following: Moderate…

Read the full statement (122 words)

The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:

Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.

The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.

Indications for use as stated in the FDA summary.

More from Imaging Therapeutics, Inc.

2 FDA decisions under this applicant name. See the company

  • K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008

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
  • K022779Oti Unicondular Interpositional SpacerOsteoimplant Technology, Inc. · 2002
  • K003269Unicondylar Interpositional SpacerSulzer Orthopedics, Inc. · 2001

https://510kreport.com/device/K033242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033242: Knee Interpositional Mini-Repair System (Kimrs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033242

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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