510(k) · Cleared
ClearedMak Oss Femoral Knee Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Oct 24, 2013 as substantially equivalent to K083779 (Biomet Manufacturing Corp, 2009) and 1 other predicate after a 162-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 24, 2013
- Review
- 162 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002757 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002757 Oncology Salvage SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK021260 Reduced Size Oncology Salvage SystemBiomet, Inc. · 2002
- 2 generations backK051479 RS (Reduced Size) Oss (Orthopedic Salvage System) Additional…Biomet Manufacturing, Inc. · 2005
- 1 generation backK083779 Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009 · Recalled
- This deviceK131393 Mak Oss Femoral Knee ComponentsBiomet Orthopedics Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002757 | Oncology Salvage System | Biomet, Inc. | 2000 | 14 |
| −3 | K021260 | Reduced Size Oncology Salvage System | Biomet, Inc. | 2002 | — |
| −2 | K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components | Biomet Manufacturing, Inc. | 2005 | — |
| −1 | K083779 | Mak Oss Knee Femoral Components | Biomet Manufacturing Corp | 2009 | 1 |
| 0 (this device) | K131393 | Mak Oss Femoral Knee Components | Biomet Orthopedics Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
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 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083779 | Mak Oss Knee Femoral ComponentsSummary page 1…RO) - Knee joint femorotibial metal/polymer constrained cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K083779 - MAK OSS Femoral Knee Components (lBiomet) K 123501 -Orthopedic Salvage System (Biomet) Device Descriptio… | 2009 |
| * | K123501 | Oss Modular Stems, Oss Diaphyseal SegmentsSummary page 1…s Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K083779 - MAK OSS Femoral Knee Components (lBiomet) K 123501 -Orthopedic Salvage System (Biomet) Device Description: The MAK 055 Femoral Knee Components are intended to be used as an option… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System 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 or revision of unsuccessful osteotomy, arthrodesis, or previous joint…
Read the full statement (188 words)
Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System 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 or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by 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).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
1. Correction or 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.
https://510kreport.com/device/K131393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131393: Mak Oss Femoral Knee Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131393
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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