510(k) · Cleared
Recalled · 2011Subtalar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 31, 2007 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 2 other predicates after a 61-day review. Its family tree reaches back 2 generations to 1980. 32 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 31, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792670 (1980). 4 ancestors in all. 32 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 1 generation backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- This deviceK071498 Subtalar ImplantBiomet Sports Medicine, Inc. · 2007
- Descendant · cites it directly · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- Descendant · 2 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 4 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · 5 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · cites it directly31descendants
- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 3 generations on15descendants
- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 4 generations on14descendants
- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −1 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| 0 (this device) | K071498 | Subtalar Implant | Biomet Sports Medicine, Inc. | 2007 | — |
| +1 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| +2 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| +4 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +5 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | K960692 | Subtalar Mba SystemSummary page 1…ooth or threaded metallic bone fixation fastener (888.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Subtalar MBA c&Implant Systemn- K960692, 07/23/1996, Kinetikos Medical Incorporated (KIVI) Subtalar Arthmirisis Implant (Conical Subtailar Implant or CSI)- K03290… | 1996 |
| * | K032902 | Subtalar Arthrorisis ImplantSummary page 1…Subtalar MBA c&Implant Systemn- K960692, 07/23/1996, Kinetikos Medical Incorporated (KIVI) Subtalar Arthmirisis Implant (Conical Subtailar Implant or CSI)- K032902, 12/15/2003, Nexa Orthopedics- Previously Futura Biomedical Ka/ixlImp/ant- K001231, 07/11/2000, New Deal- An Integr… | 2003 |
| * | K001231 | The Kalix ImplantSummary page 1…Subtalar Arthmirisis Implant (Conical Subtailar Implant or CSI)- K032902, 12/15/2003, Nexa Orthopedics- Previously Futura Biomedical Ka/ixlImp/ant- K001231, 07/11/2000, New Deal- An Integra LifeSciences Company Device Description: The Subtalar Implant isa one-piece device comprised o… | 2000 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133636 | Extremity Medical Hammertoe Device | 2014 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2011 | Not classified | Z-1618-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1614-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1613-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1615-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1616-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1617-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Jan 21, 2011 | Not classified | Z-1612-2011 | Pending | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133636 (Extremity Medical, LLC, 2014) has gone furthest, with 31 descendants of its own.
- 8 other devices also cite its predicate K960692.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot.
Examples include, but are not limited to:
* Symptomatic acquired flat foot treatment in children and adolescents
* Symptomatic congenital flexible flat foot
* Tarsal coalitions when associated with the flatfoot deformity
* Posterior tibial tendon dysfunction with supple feet
* Paralytic flat foot
* Subtalar Instability
* Severely pronated foot
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071498: Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071498
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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