510(k) Report

510(k) · Cleared

Cleared

Accin Patellofemoral System

K073120510(k) TraditionalCleared Feb 29, 2008116-day reviewClass II21 CFR 888.3540

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

Accelerated Innovation, LLC · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Feb 29, 2008 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Feb 29, 2008
Review
116 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
0

5 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2009: 1 descendant cleared2025: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK073120 Accin Patellofemoral SystemAccelerated Innovation, LLC · 2008
  2. Descendant · cites it directly · 3 of its ownK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
  3. Descendant · 2 generations on · 1 of its ownK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
  4. Descendant · cites it directly · 0 of its ownK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
  5. Descendant · cites it directly · 0 of its ownK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
  6. Descendant · cites it directly · 0 of its ownK092803 Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp. · 2009

Most influential descendants

Showing 5 of 5 · See all
  • K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016 · cites it directly3descendants
  • K200433iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020 · 2 generations on1descendant
  • K251453Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025 · cites it directly0descendants
  • K171365Arthrex Knee SystemsArthrex, Inc. · 2017 · cites it directly0descendants
  • K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073120Accin Patellofemoral SystemAccelerated Innovation, LLC2008—
+1K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.2016—
+2K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.2020—
+1K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.2025—
+1K171365Arthrex Knee SystemsArthrex, Inc.2017—
+1K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201610
201710
202010
202510
FIG. 1 — Lineage of K073120, 2008–2025Source: 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 KRR? 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 KRR device

  1. #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163
K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250
K171365Arthrex Knee SystemsArthrex, Inc.20170
K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp.20090

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, K160461 (Arthrex, Inc., 2016) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KRR devices

KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KRR

1in 2023

2007: 22008: 32012: 12013: 12015: 12016: 12018: 12020: 12021: 12022: 12023: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRR

116in 2008

2008: 116 days median
2007high 116 (2008)2026

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

Recalls per year · KRR

3in 2022

2013: 12016: 12017: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KRR

36in 2025

2009: 122010: 62011: 32012: 92013: 92014: 262015: 182016: 142017: 152018: 142019: 162020: 62021: 82022: 92023: 122024: 252025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code KRR, 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
20072—00
2008311600
20090—012
20100—06
20110—03
20121—09
20131—19
20140—026
20151—018
20161—114
20170—215
20181—014
20190—016
20201—06
20211—08
20221—39
20231—012
20240—025
20250—036
20260—0—
Cite this page

510(k) Report. “K073120: Accin Patellofemoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073120

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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