510(k) · Cleared
ClearedRTS Lesser MTP Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Feb 23, 2018 as substantially equivalent to K022886 (Osteomed Corp., 2002) and 1 other predicate after a 102-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 23, 2018
- Review
- 102 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884739 (1989). 4 ancestors in all, the oldest K820813 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK884739 Sgarlato Lesser Toe ImplantSgarlato Laboratories, Inc. · 1989
- 1 generation backK022886 Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
- This deviceK173491 RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
- Descendant · cites it directly · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884739 | Sgarlato Lesser Toe Implant | Sgarlato Laboratories, Inc. | 1989 | — |
| −1 | K022886 | Metatarsophalangeal Flexible Stabilizing Rod System | Osteomed Corp. | 2002 | — |
| 0 (this device) | K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018 | — |
| +1 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemSummary page 6…Page 6 of 21 K173491 - Page 2 of 2 Primary Predicate • K022886 – OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System Additional Predicate • K023531 – Integra Lesser Metatarsal Pha… | 2002 |
| * | K023531 | Lesser Metatarsal Phalangeal Joint ImplantSummary page 6…K173491 - Page 2 of 2 Primary Predicate • K022886 – OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System Additional Predicate • K023531 – Integra Lesser Metatarsal Phalangeal Implant Reference Device • K153609 – In2Bones RTS® Flexible 1st MPJ Implant w/Grommets… | 2003 |
| † | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | 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 |
|---|---|---|---|
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan… | 2019 | 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 29 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K190385 (In2bones USA, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022886.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RTS® Lesser MTP Implant is intended for use in the treatment of:
• Partial or complete dislocation of the lesser metatarsophalangeal joint
• Pain associated with either rheumatoid or osteoarthritis
• Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173491: RTS Lesser MTP Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173491
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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