510(k) Report

510(k) · Cleared

Cleared

Compress Distal Femoral Replacement System

K041352510(k) TraditionalCleared Jul 30, 200471-day reviewClass II21 CFR 888.3510

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

Biomet, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Cleared on Jul 30, 2004 as substantially equivalent to K031804 (Biomet, Inc., 2003) and 3 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1996. 12 later devices descend from it.

Decided
Jul 30, 2004
Review
71 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K945028 (1996). 4 ancestors in all. 12 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 1 other ancestor2005: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK945028 · Finn Knee System · Biomet, Inc. · 1996K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 2003K945028 · Finn Knee System · Biomet, Inc. · 19960+5
  1. Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
  2. 1 generation backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
  3. This deviceK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
  4. Descendant · cites it directly · 11 of its ownK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 10 of its ownK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
  6. Descendant · 3 generations on · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
  7. Descendant · 4 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
  8. Descendant · 2 generations on · 2 of its ownK080330 Segmental Distal Femoral Components and Proximal Femoral Bodies with…Biomet, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12008: 12010: 12012: 22015: 12018: 12019: 12023: 12025: 12026: 1
2005high 2 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all
  • K043547Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · cites it directly11descendants
  • K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp · 2007 · 2 generations on10descendants
  • K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · 3 generations on5descendants
  • K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 4 generations on2descendants
  • K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc. · 2008 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945028Finn Knee SystemBiomet, Inc.1996—
−1K031804Compress Distal Femoral ReplacementBiomet, Inc.2003—
0 (this device)K041352Compress Distal Femoral Replacement SystemBiomet, Inc.2004—
+1K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.20056
+2K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp200721
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC20122
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018—
+2K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a…Biomet, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200810
201010
201220
201510
201810
201910
202310
202510
202610
FIG. 1 — Lineage of K041352, 1996–2026Source: 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), 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 KRO? 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 KRO device

  1. #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 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? (4)

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
*K031804Compress Distal Femoral Replacement
Summary page 1
…(21 CFR §888.3510). Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. ComPreSs® Distal Femoral Replacement - Biomet Inc. (K031804). 2. Modular Replacement System -Howmedicalnc.(K972401). 3. Finn® Knee System - Biomet Inc. (K945…
Biomet, Inc.2003—
*K972401Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments
Summary page 1
…al Equivalence Is Claimed: 1. ComPreSs® Distal Femoral Replacement - Biomet Inc. (K031804). 2. Modular Replacement System -Howmedicalnc.(K972401). 3. Finn® Knee System - Biomet Inc. (K945028). 4. Oncology Salvage System - Biomet Inc. (K002757…
Howmedica Corp.1998—
*K945028Finn Knee System
Summary page 1
…l Femoral Replacement - Biomet Inc. (K031804). 2. Modular Replacement System -Howmedicalnc.(K972401). 3. Finn® Knee System - Biomet Inc. (K945028). 4. Oncology Salvage System - Biomet Inc. (K002757). Device Description: The CompreSs® Distal…
Biomet, Inc.1996—
*K002757Oncology Salvage System
Summary page 1
…dular Replacement System -Howmedicalnc.(K972401). 3. Finn® Knee System - Biomet Inc. (K945028). 4. Oncology Salvage System - Biomet Inc. (K002757). Device Description: The CompreSs® Distal Femoral Replacement System consists of three main…
Biomet, Inc.200014

Also cleared against K031804: 1 other device →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.200511

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 8 years and passes through 1 company; a new generation was cleared every 7.8 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K043547 (Biomet, Inc., 2005) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K031804.

How does its category compare?

All KRO devices

KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRO

3in 2025

2007: 12008: 32009: 32010: 12011: 22012: 22013: 32014: 22015: 62016: 32017: 12019: 32020: 12021: 32022: 12023: 42024: 32025: 32026 (partial year): 1
2007high 6 (2015) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRO

56in 2025

2008: 126 days median2009: 86 days median2013: 189 days median2015: 113 days median2016: 148 days median2019: 244 days median2021: 57 days median2023: 148 days median2024: 87 days median2025: 56 days median
2007high 244 (2019) · low 56 (2025)2026

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

Recalls per year · KRO

14so far in 2026, the most since 2007

2007: 12008: 32009: 82011: 12012: 12013: 22015: 12016: 52017: 42018: 12021: 12025: 12026 (partial year): 14
2007high 14 (2026) · low 0 (2010)2026

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

Adverse event reports per year · KRO

915in 2025

2007: 372008: 442009: 662010: 1102011: 1192012: 1732013: 1942014: 4062015: 3332016: 3692017: 5432018: 6142019: 7592020: 7492021: 7702022: 8922023: 7462024: 8552025: 915
2007high 915 (2025) · low 37 (2007)2025

MAUDE reports naming product code KRO, 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
20071—137
20083126344
2009386866
20101—0110
20112—1119
20122—1173
201331892194
20142—0406
201561131333
201631485369
20171—4543
20180—1614
201932440759
20201—0749
20213571770
20221—0892
202341480746
20243870855
20253561915
20261—14—

What is it indicated for?

1) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

2) Tumor resections

3) Revision of previously failed total joint arthroplasty

4) Trauma

The ComPreSs® Distal Femoral Replacement components are intended for uncemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K031804

1 other device cites the same predicate.

  • K043547Compress Segmental Femoral Replacement SystemBiomet, Inc. · 20056 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in KRO

The KRO category page

  • K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
  • K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20251 recall
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  • K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC · 202411 recalls

https://510kreport.com/device/K041352 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041352: Compress Distal Femoral Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041352

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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