510(k) Report

510(k) · Cleared

Cleared

Reduced Size Oncology Salvage System

K021260510(k) TraditionalCleared Jun 5, 200247-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 5, 2002 as substantially equivalent to K002757 (Biomet, Inc., 2000) after a 47-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided
Jun 5, 2002
Review
47 days
Class
Class II
Product code
KRO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002757 (2000). 7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 2 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2026: 1 descendant cleared2013: 1 descendant clearedK002757 · Oncology Salvage System · Biomet, Inc. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K002757 · Oncology Salvage System · Biomet, Inc. · 2000 · recalled0
  1. Root · 1 generation backK002757 Oncology Salvage SystemBiomet, Inc. · 2000 · Recalled
  2. This deviceK021260 Reduced Size Oncology Salvage SystemBiomet, Inc. · 2002
  3. Descendant · cites it directly · 6 of its ownK051479 RS (Reduced Size) Oss (Orthopedic Salvage System) Additional…Biomet Manufacturing, Inc. · 2005
  4. Descendant · cites it directly · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
  5. Descendant · cites it directly · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK083779 Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12013: 12014: 12015: 22026: 1
2005high 2 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K051479RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsBiomet Manufacturing, Inc. · 2005 · cites it directly6descendants
  • K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · cites it directly3descendants
  • K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · cites it directly1descendant
  • K083779Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009 · 2 generations on1descendant
  • 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
−1K002757Oncology Salvage SystemBiomet, Inc.200014
0 (this device)K021260Reduced Size Oncology Salvage SystemBiomet, Inc.2002—
+1K051479RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsBiomet Manufacturing, Inc.2005—
+1K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.2014—
+1K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC20156
+2K083779Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp20091
+2K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201310
201410
201520
202610
FIG. 1 — Lineage of K021260, 2000–2026Source: 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? (1)

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
*K002757Oncology Salvage System
Summary page 1
…ted, metal/polymer (888.3510) Device Product Code: 87KRO Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Oncology Salvage System, K002757, Biomet, Inc. Indications for Use: The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for trea…
Biomet, Inc.200014

Also cleared against K002757: 20 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K051479RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsBiomet Manufacturing, Inc.20056
K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.20143
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?

  • Its one ancestor has a recall.
  • Of its descendants, K051479 (Biomet Manufacturing, Inc., 2005) has gone furthest, with 6 descendants of its own.
  • 20 other devices also cite its predicate K002757.

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 Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. Indications: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis 2. Correction of…

Read the full statement (125 words)

The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur.

Indications:

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 device components are for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K002757

20 other devices cite the same predicate.

  • K190100USTAR II SystemUnited Orthopedic Corporation · 20195 recalls
  • K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
  • K123501Oss Modular Stems, Oss Diaphyseal SegmentsBiomet, Inc. · 2013
  • K121056Mets Modular Proximal FemurStanmore Implants Worldwide, Ltd. · 2012
  • K121055Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012
  • K121029Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012

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/K021260 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021260: Reduced Size Oncology Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021260

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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