510(k) · Cleared
ClearedAvl Hinge Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Aug 5, 2005 as substantially equivalent to K010774 (Biomet, Inc., 2001) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Aug 5, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K945028 (1996). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945028 Finn Knee SystemBiomet, Inc. · 1996
- This deviceK051570 Avl Hinge Knee SystemBiomet, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK140898 Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K120992Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
- K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · 2 generations on2descendants
- K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015 · 2 generations on0descendants
- K140898Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| 0 (this device) | K051570 | Avl Hinge Knee System | Biomet, Inc. | 2005 | — |
| +1 | K120992 | Mets Smiles Total Knee Replacement | Stanmore Implants Worldwide, Ltd. | 2012 | 6 |
| +2 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
| +2 | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
| +3 | K140898 | Patient Specific Distal Femoral | Stanmore Implants Worldwide, Ltd. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K010774 | Avl Hinge Knee SystemSummary page 1…The AVL Hinge Knee System is Legally Marketed Devices To Which Substantial Equivalence Hinge Knee System (K010774); Orthopedic Salvage substantially equivalent to the following Biornet products: AVL System (QSSTM) (K002757); Finn® Knee System… | 2001 |
| * | K002757 | Oncology Salvage SystemSummary page 1…Hinge Knee System (K010774); Orthopedic Salvage substantially equivalent to the following Biornet products: AVL System (QSSTM) (K002757); Finn® Knee System (K945028). of a modular femoral component t… | 2000 |
| * | K945028 | Finn Knee SystemSummary page 1…Hinge Knee System (K010774); Orthopedic Salvage substantially equivalent to the following Biornet products: AVL System (QSSTM) (K002757); Finn® Knee System (K945028). of a modular femoral component that is joined to a Device Des… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120992 | Mets Smiles Total Knee Replacement | 2012 | 3 |
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?
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.
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?
The indications for use of the AVL Hinge Knee 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 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 for cemented use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051570: Avl Hinge Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051570
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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