510(k) Report

510(k) · Cleared

Cleared

Mako Surgical Corp. Patellofemoral Knee Implant System II

K082088510(k) TraditionalCleared Oct 22, 200890-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

Mako Surgical Corp. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Oct 22, 2008 as substantially equivalent to K080029 (Mako Surgical Corp., 2008) and 4 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.

Decided
Oct 22, 2008
Review
90 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K020841 (2002). 5 ancestors in all, the oldest K010100 (2001). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2013: 1 descendant cleared2015: 1 descendant clearedK020841 · Avon Patellar Component · Howmedica Osteonics Corp. · 2002K080029 · Mako Surgical Corp. Patellofemoral Knee Implant System · Mako Surgical Corp. · 2008200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K080029 · Mako Surgical Corp. Patellofemoral Knee Implant System · Mako Surgical Corp. · 2008K020841 · Avon Patellar Component · Howmedica Osteonics Corp. · 20020
  1. Root · 2 generations backK020841 Avon Patellar ComponentHowmedica Osteonics Corp. · 2002
  2. 1 generation backK080029 Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp. · 2008
  3. This deviceK082088 Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
  4. Descendant · cites it directly · 1 of its ownK123907 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral…Biomet Manufacturing Corp · 2013 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK143543 Prelude PF PatellaeBiomet, Inc. · 2015 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp · 2013 · cites it directly1descendant
  • K143543Prelude PF PatellaeBiomet, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K020841Avon Patellar ComponentHowmedica Osteonics Corp.2002—
−1K080029Mako Surgical Corp. Patellofemoral Knee Implant SystemMako Surgical Corp.2008—
0 (this device)K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp.2008—
+1K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components…Biomet Manufacturing Corp20131
+2K143543Prelude PF PatellaeBiomet, Inc.20151

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
FIG. 1 — Lineage of K082088, 2002–2015Source: 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 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 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? (5)

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
*K080029Mako Surgical Corp. Patellofemoral Knee Implant System
Summary page 1
…Equivalence: The MAKO Surgical Corp. Patellofemoral Knee Implant System 1I(MPFII) is substantially equivalent to MAKO Surgical Corp. Patellofemoral Knee Implant System (K080029), Stryker Corporation's Avon T Patellofemnoral Joint Prosthesis (510k # KO1OIOO); Avon TMPatellar Component (510k # K020841); Avo…
Mako Surgical Corp.2008—
*K010100Avon Patello-Femoral Joint ProsthesisHowmedica Osteonics Corp.2001—
*K020841Avon Patellar Component
Summary page 1
…cal Corp. Patellofemoral Knee Implant System (K080029), Stryker Corporation's Avon T Patellofemnoral Joint Prosthesis (510k # KO1OIOO); Avon TMPatellar Component (510k # K020841); Avon TMExtra Small Patellofemnoral Replacement (510k # K041160); and AvonTM PFJ Prosthesis [additional patella components] (510…
Howmedica Osteonics Corp.2002—
*K041160Avon Extra-Small Patello-Femoral Replacement
Summary page 1
…orporation's Avon T Patellofemnoral Joint Prosthesis (510k # KO1OIOO); Avon TMPatellar Component (510k # K020841); Avon TMExtra Small Patellofemnoral Replacement (510k # K041160); and AvonTM PFJ Prosthesis [additional patella components] (510Ok # K051948). Feature…
Howmedica Osteonics Corp.2004—
*K051948Avon Patello-Femoral Joint Prosthesis
Summary page 1
…MPatellar Component (510k # K020841); Avon TMExtra Small Patellofemnoral Replacement (510k # K041160); and AvonTM PFJ Prosthesis [additional patella components] (510Ok # K051948). Feature MAK SugclC[.Ptloeoa neIpant System 11…
Howmedica Osteonics Corp.20057

Also cleared against K080029: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…Biomet Manufacturing Corp20131

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?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K123907 (Biomet Manufacturing Corp, 2013) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K080029.

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—

What is it indicated for?

The MAKO Surgical Corp, Patellofemoral Knee Implant System is intended to be used in cemented

patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients

with a history of patellar dislocation or patella fracture, or patients with failed previous surgery

(arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K080029

2 other devices cite the same predicate.

  • K123907Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella…Biomet Manufacturing Corp · 20131 recall
  • K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 20082 recalls

More from Mako Surgical Corp.

33 FDA decisions under this applicant name. See the company

  • K260222Mako Total Knee ApplicationMako Surgical Corp. · 2026
  • K250608Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp. · 2025
  • K243751Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
  • K242373Mako Shoulder Application (1.0)Mako Surgical Corp. · 2024
  • K241011Mako Total Knee ApplicationMako Surgical Corp. · 20241 recall

Recent decisions in KRR

The KRR category page

  • K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
  • K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
  • K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  • K200122MOTO PFJ SystemMedacta International S.A. · 2020
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls

https://510kreport.com/device/K082088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082088: Mako Surgical Corp. Patellofemoral Knee Implant System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082088

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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