510(k) · Cleared
ClearedInCore Subtalar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 21, 2021 as substantially equivalent to K140891 (Biomet, Inc., 2014) and 1 other predicate after an 81-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Dec 21, 2021
- Review
- 81 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922322 (1992). 29 ancestors in all, the oldest K872859 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
- 4 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- 3 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
- 2 generations backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
- 1 generation backK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- This deviceK213301 InCore Subtalar SystemNextremity Solutions, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922322 | Alphatec 3.5MM Znnulated Cortical Lag Screw | Alphatec Mfg., Inc. | 1992 | — |
| −4 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| −3 | K024086 | Propeller Head Small Cannulated Screw System | Biomet Orthopedics, Inc. | 2003 | — |
| −2 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
| −1 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| 0 (this device) | K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K140891 | Biomet Cannulated Screw SystemSummary page 4…Product Code: HWC Substantially Equivalent Devices: • Zimmer Biomet, TiMAX™ Cannulated Screw System (Cleared as Biomet Cannulated Screw System), K140891-Primary Predicate • Nextremity Solutions, Stratum Foot Plating System, K182201-Additional Predicate Device Description: The… | 2014 |
| * | K182201 | Stratum™ Foot Plating SystemSummary page 4…t, TiMAX™ Cannulated Screw System (Cleared as Biomet Cannulated Screw System), K140891-Primary Predicate • Nextremity Solutions, Stratum Foot Plating System, K182201-Additional Predicate Device Description: The InCore® Subtalar System consists of a post and two headless compression screws. Post… | 2018 |
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 29 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 5 other devices also cite its predicate K140891.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213301: InCore Subtalar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213301
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