510(k) Report

510(k) · Cleared

Cleared

Compress Distal Femoral Replacement

K031804510(k) TraditionalCleared Dec 18, 2003190-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 Dec 18, 2003 as substantially equivalent to K945028 (Biomet, Inc., 1996) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it.

Decided
Dec 18, 2003
Review
190 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K945028 (1996). 2 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2005: 1 descendant cleared2004: 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. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K945028 · Finn Knee System · Biomet, Inc. · 19960+5
  1. Root · 1 generation backK945028 Finn Knee SystemBiomet, Inc. · 1996
  2. This deviceK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
  3. Descendant · cites it directly · 12 of its ownK041352 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

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12007: 12008: 12010: 12012: 22015: 12018: 12019: 12023: 12025: 12026: 1
2004high 2 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 13 · See all
  • K041352Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004 · cites it directly12descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945028Finn Knee SystemBiomet, Inc.1996—
0 (this device)K031804Compress Distal Femoral ReplacementBiomet, Inc.2003—
+1K041352Compress 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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200710
200810
201010
201220
201510
201810
201910
202310
202510
202610
FIG. 1 — Lineage of K031804, 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? (2)

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
*K945028Finn Knee System
Summary page 1
…Device Classification: Class II Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Finn Knee System - Biomet Inc. (K945028) 2. Modular Replacement System - Howmedica Inc. (K972401) Device Description: The…
Biomet, Inc.1996—
*K972401Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments
Summary page 1
…Substantial Equivalence Is Claimed: 1. Finn Knee System - Biomet Inc. (K945028) 2. Modular Replacement System - Howmedica Inc. (K972401) Device Description: The ComPreSs TM Distal Femoral Replacement is a metallic femoral…
Howmedica Corp.1998—

Also cleared against K945028: 4 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K041352Compress Distal Femoral Replacement SystemBiomet, Inc.200412
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K041352 (Biomet, Inc., 2004) has gone furthest, with 12 descendants of its own.
  • 4 other devices also cite its predicate K945028.

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?

The ComPreSsTM Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.

The ComPreSsTM Distal Femoral Replacement components are intended for uncemented use.

Indications for use as stated in the FDA summary.

Also cleared against K945028

4 other devices cite the same predicate.

  • K051570Avl Hinge Knee SystemBiomet, Inc. · 2005
  • K041352Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
  • K020381Expandable KneeBiomet Orthopedics, Inc. · 20022 recalls
  • K013385Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 20022 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/K031804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031804: Compress Distal Femoral Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031804

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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