510(k) · Cleared
ClearedSubtalar Mba System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetikos Medical, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 23, 1996 as substantially equivalent to K792670 (Dow Corning Wright, 1980) after a 154-day review. Its family tree reaches back 1 generation to 1980. 57 later devices descend from it.
- Decided
- Jul 23, 1996
- Review
- 154 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K792670 (1980). 57 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK792670 Smith Subtalar PegDow Corning Wright · 1980
- This deviceK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- Descendant · cites it directly · 32 of its ownK071498 Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- Descendant · 3 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · cites it directly · 16 of its ownK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
- Descendant · 4 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · cites it directly32descendants
- K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on16descendants
- K031155Osteomed Subtalar Implant SystemOsteomed LP · 2003 · cites it directly16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| 0 (this device) | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| +1 | K071498 | Subtalar Implant | Biomet Sports Medicine, Inc. | 2007 | 7 |
| +2 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| +3 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +1 | K031155 | Osteomed Subtalar Implant System | Osteomed LP | 2003 | — |
| +4 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K792670 | Smith Subtalar PegSummary page 3…is product is substantially equivalent in design, composition and/or function to another orthopedic implant device manufactured and approved for market. Wright Medicak: K792670 The KMI Subtalar MBA System™ meets the ASTM standards (ASTM B348-83, F136- 84, F67-88) for material and design of implants for m… | 1980 |
What descends from it? (57)
See all 579 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071498 | Subtalar Implant | 2007 | 32 |
| K031155 | Osteomed Subtalar Implant System | 2003 | 16 |
| K051611 | Mbaresorb Implant | 2005 | 10 |
| K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | 2010 | 8 |
| K103183 | Trilliant Surgical Subtalar Implant | 2011 | 4 |
| K032682 | STS Screw | 2003 | 3 |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot… | 2021 | 0 |
| K053543 | Arthrex Arthoeresis Implant | 2006 | 0 |
| K041936 | Biopro Subtalar Implant | 2004 | 0 |
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 HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960692: Subtalar Mba System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960692
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