510(k) · Cleared
ClearedRTS Flexible 1 MPJ Implant w/Grommets
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 Sep 8, 2016 as substantially equivalent to K981194 (Nexa Orthopedics, Inc., 1998) after a 266-day review. Its family tree reaches back 2 generations to 1978. 2 later devices descend from it.
- Decided
- Sep 8, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780132 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
- 1 generation backK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
- This deviceK153609 RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
- Descendant · cites it directly · 0 of its ownK191966 NewPrim SystemBrm Extremities · 2020
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780132 | Implant, Hinge Toe, Flex. | Dow Corning Corp. Healthcare Industries Materials | 1978 | — |
| −1 | K981194 | Futura Biomedical Flexible Great Toe Implant | Nexa Orthopedics, Inc. | 1998 | — |
| 0 (this device) | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016 | — |
| +1 | K191966 | NewPrim System | Brm Extremities | 2020 | — |
| +1 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K981194 | Futura Biomedical Flexible Great Toe ImplantSummary page 4…87 KWH III. Predicate Device Predicate Device: Futura Biomedical, Flexible Great Toe Implant K981194 IV. Device Description The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesi… | 1998 |
What descends from it? (2)
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?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 20.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191966 (Brm Extremities, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981194.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:
Hallux limitus or hallux rigidus
Painful rheumatoid arthritis
Hallux abducto valgus associated with arthritis
Unstable or painful joint from previous surgery
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/K153609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153609: RTS Flexible 1 MPJ Implant w/Grommets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153609
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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