510(k) Report

510(k) · Cleared

Cleared

Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper

K080330510(k) TraditionalCleared Jun 11, 2008126-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 Jun 11, 2008 as substantially equivalent to K043547 (Biomet, Inc., 2005) and 3 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.

Decided
Jun 11, 2008
Review
126 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K945028 (1996). 9 ancestors in all, the oldest K952970 (1996). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2015: 1 descendant cleared2026: 1 descendant clearedK945028 · Finn Knee System · Biomet, Inc. · 1996K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 2003K041352 · Compress Distal Femoral Replacement System · Biomet, Inc. · 2004K043547 · Compress Segmental Femoral Replacement System · Biomet, Inc. · 2005 · recalledK062998 · Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) · Biomet Manufacturing Corp · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K062998 · Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) · Biomet Manufacturing Corp · 2007 · recalledK043547 · Compress Segmental Femoral Replacement System · Biomet, Inc. · 2005 · recalledK041352 · Compress Distal Femoral Replacement System · Biomet, Inc. · 2004K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 2003K945028 · Finn Knee System · Biomet, Inc. · 1996−50
  1. Root · 5 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
  2. 4 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
  3. 3 generations backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
  4. 2 generations backK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
  5. 1 generation backK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
  6. This deviceK080330 Segmental Distal Femoral Components and Proximal Femoral Bodies with…Biomet, Inc. · 2008
  7. Descendant · cites it directly · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · cites it directly1descendant
  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945028Finn Knee SystemBiomet, Inc.1996—
−4K031804Compress Distal Femoral ReplacementBiomet, Inc.2003—
−3K041352Compress Distal Femoral Replacement SystemBiomet, Inc.2004—
−2K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.20056
−1K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp200721
0 (this device)K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a…Biomet, Inc.2008—
+1K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC20156
+2K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200010
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202610
FIG. 1 — Lineage of K080330, 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
*K043547Compress Segmental Femoral Replacement System
Summary page 1
…rained, Cemented Prosthesis (21 CFR §888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Compress® Segmental Femoral Replacement System K043547 & K062998 * Orthopedic Salvage System (OSSTM) K002757& K052685 Device Description: The Segmental Distal Femora…
Biomet, Inc.20056
*K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)
Summary page 1
…mented Prosthesis (21 CFR §888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Compress® Segmental Femoral Replacement System K043547 & K062998 * Orthopedic Salvage System (OSSTM) K002757& K052685 Device Description: The Segmental Distal Femoral Componen…
Biomet Manufacturing Corp200721
*K002757Oncology Salvage System
Summary page 1
…es To Which Substantial Equivalence Is Claimed: * Compress® Segmental Femoral Replacement System K043547 & K062998 * Orthopedic Salvage System (OSSTM) K002757& K052685 Device Description: The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the d…
Biomet, Inc.200014
*K052685Orthopedic Salvage System- Oss
Summary page 1
…ch Substantial Equivalence Is Claimed: * Compress® Segmental Femoral Replacement System K043547 & K062998 * Orthopedic Salvage System (OSSTM) K002757& K052685 Device Description: The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end…
Biomet, Inc.20052

Also cleared against K043547: 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
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC20151

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 12 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 5 of the 9 ancestors have a recall of any class.
  • Of its descendants, K142814 (Biomet Manufacturing, LLC, 2015) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K043547.

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. 2008, this device’s year, is highlighted.

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?

Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis. 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy…

Read the full statement (167 words)

Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.

2. Correction of varus, valgus or post traumatic deformity

3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

4. Ligament deficiencies

5. Tumor resections

6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

7. Revision of previously failed total joint arthroplasty

8. Trauma

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA)

When used with Biomet's Compress ® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:

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.

Indications for use as stated in the FDA summary.

Also cleared against K043547

2 other devices cite the same predicate.

  • K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp · 2010
  • K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp · 200721 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/K080330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080330

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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