510(k) · Cleared
ClearedSubtalar Peg Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · MJW Prosthesis, Subtalar, Plug, Polymer
Cleared on Dec 23, 2003 as substantially equivalent to K792670 (Dow Corning Wright, 1980) after an 85-day review. Its family tree reaches back 1 generation to 1980. 9 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- MJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K792670 (1980). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK792670 Smith Subtalar PegDow Corning Wright · 1980
- This deviceK033046 Subtalar Peg ImplantNexa Orthopedics, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- Descendant · 2 generations on · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- Descendant · 2 generations on · 2 of its ownK122738 Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010 · cites it directly8descendants
- K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on4descendants
- K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 3 generations on3descendants
- K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · cites it directly2descendants
- K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012 · 2 generations on2descendants
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) | K033046 | Subtalar Peg Implant | Nexa Orthopedics, Inc. | 2003 | — |
| +1 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| +2 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +3 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +1 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| +2 | K122738 | Gaitway Implant System, Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 MJW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K792670 | Smith Subtalar PegSummary page 4…eg Implant Device Trade Name: Subtalar Peg Implant Device Classification: Class Il Reviewing Panel: Orthopedic Regulation Number Product Code: ~ 87 MIW Predicate Device: K792670- Smith Subtalar Peg Registration Number: 2030833 Owner Operator Number: 9028319 Device Description: ‘I'he Futura Biomedical Impl… | 1980 |
| * | — | Wright Medical STA-Peg implant Named without a submission number |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 MJW devicesMJW Prosthesis, Subtalar, Plug, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJW
FDA has decided no MJW device since 2007.
Median 510(k) review, days · MJW
Too few MJW 510(k)s in any year since 2007 to give a median.
Recalls per year · MJW
No recall names MJW since 2007.
Adverse event reports per year · MJW
1in 2017
MAUDE reports naming product code MJW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Examples include:
Flat foot treatment in children and adolescents
Congenital flat foot
Unsuccessful long term orthopaedic treatment (shoes, insoles...)
Tarsal coalitions
Painful flat foot
Supple deformity in posterior tibial tendon dysfunction
Paralytic flat foot
Subtalar instability
This device is intended to be fixed with bonc cement.
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/K033046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033046: Subtalar Peg Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033046
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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