510(k) · Cleared
ClearedPIT’Stop® implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HWC Screw, Fixation, Bone
Cleared on Nov 28, 2017 as substantially equivalent to K061765 (New Deal, S.A., 2006) and 2 other predicates after a 266-day review. Its family tree reaches back 6 generations to 1980. 1 later device descends from it.
- Decided
- Nov 28, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K792670 (1980). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 5 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 4 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 3 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 2 generations backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- 1 generation backK122738 Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
- This deviceK170688 PIT’Stop® implantIn2bones Sas · 2017
- Descendant · cites it directly · 0 of its ownK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Most influential descendants
Showing 1 of 1 · See all- K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −5 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −4 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −3 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −2 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| −1 | K122738 | Gaitway Implant System, Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
| 0 (this device) | K170688 | PIT’Stop® implant | In2bones Sas | 2017 | — |
| +1 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K061765 | Kalix II ImplantSummary page 5…Sterilization: The PIT’Stop® implant is supplied sterile, using gamma irradiation. Predicate Devices Newdeal KALIX® II Flat foot implant (K061765) Solana Surgical, LLC, Gaitway Implant System (K122738) In2Bones OS2®-VP varisation… | 2006 |
| * | K122738 | Gaitway Implant System, Surgical Instrument SetSummary page 5…gamma irradiation. Predicate Devices Newdeal KALIX® II Flat foot implant (K061765) Solana Surgical, LLC, Gaitway Implant System (K122738) In2Bones OS2®-VP varisation staple (K153770) Indications for use: The PIT’Stop® implant is indicated fo… | 2012 |
| * | K153770 | OS2(R)-VP Varisation StapleSummary page 5…® II Flat foot implant (K061765) Solana Surgical, LLC, Gaitway Implant System (K122738) In2Bones OS2®-VP varisation staple (K153770) Indications for use: The PIT’Stop® implant is indicated for use in the treatment of the hyperpronated f… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | 2022 | 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?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K222820 (Brm Extremities, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 PIT’Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint.
It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint
motion but blocking excessive pronation and the resulting sequela.
- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes, insoles...)
- Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instability
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/K170688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170688: PIT’Stop® implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170688
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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