510(k) · Cleared
Recalled · 2012Mak Oss Knee Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Apr 3, 2009 as substantially equivalent to K002757 (Biomet, Inc., 2000) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 3, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002757 (2000). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002757 Oncology Salvage SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK021260 Reduced Size Oncology Salvage SystemBiomet, Inc. · 2002
- 1 generation backK051479 RS (Reduced Size) Oss (Orthopedic Salvage System) Additional…Biomet Manufacturing, Inc. · 2005
- This deviceK083779 Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009
- Descendant · cites it directly · 0 of its ownK131393 Mak Oss Femoral Knee ComponentsBiomet Orthopedics Corp. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131393Mak Oss Femoral Knee ComponentsBiomet Orthopedics Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002757 | Oncology Salvage System | Biomet, Inc. | 2000 | 14 |
| −2 | K021260 | Reduced Size Oncology Salvage System | Biomet, Inc. | 2002 | — |
| −1 | K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components | Biomet Manufacturing, Inc. | 2005 | — |
| 0 (this device) | K083779 | Mak Oss Knee Femoral Components | Biomet Manufacturing Corp | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K002757 | Oncology Salvage SystemSummary page 1…lymer constrained cemented prosthesis (21 CFR 888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K002757 Oncology Salvage System K051479 RS (Reduced Size) 055 (Orthopedic Salvage System) Component K052685 Orthoped… | 2000 |
| * | K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsSummary page 1…prosthesis (21 CFR 888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K002757 Oncology Salvage System K051479 RS (Reduced Size) 055 (Orthopedic Salvage System) Component K052685 Orthopedic Salvage System - COSS Device Descript… | 2005 |
| * | K052685 | Orthopedic Salvage System- OssSummary page 1…To Which Substantial Equivalence Is Claimed: K002757 Oncology Salvage System K051479 RS (Reduced Size) 055 (Orthopedic Salvage System) Component K052685 Orthopedic Salvage System - COSS Device Description: There are two styles of MAK OSS Knee Femoral components, resurfacing and… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131393 | Mak Oss Femoral Knee Components | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2012 | Not classified | Z-1438-2012 | Component design/selection | Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K131393 (Biomet Orthopedics Corp., 2013) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K002757.
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. 2009, 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 OSS Knee System is intended for use in total knee replacement. 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…
Read the full statement (98 words)
Biomet's OSS Knee System is intended for use in total knee replacement. 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 arthroplasy.
8.. Trauma
These devices are to be used with bone cement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083779: Mak Oss Knee Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083779
Report an extraction error
Are you the manufacturer?
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