510(k) · Cleared
ClearedNewPrim System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brm Extremities · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Feb 13, 2020 as substantially equivalent to K153609 (In2bones USA, LLC, 2016) after a 205-day review. Its family tree reaches back 3 generations to 1978.
- Decided
- Feb 13, 2020
- Review
- 205 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780132 (1978). No later device cites it as a predicate yet.
- Root · 3 generations backK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
- 2 generations backK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
- 1 generation backK153609 RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
- This deviceK191966 NewPrim SystemBrm Extremities · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780132 | Implant, Hinge Toe, Flex. | Dow Corning Corp. Healthcare Industries Materials | 1978 | — |
| −2 | K981194 | Futura Biomedical Flexible Great Toe Implant | Nexa Orthopedics, Inc. | 1998 | — |
| −1 | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016 | — |
| 0 (this device) | K191966 | NewPrim System | Brm Extremities | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K153609 | RTS Flexible 1 MPJ Implant w/GrommetsSummary page 5…l and base of the proximal phalanx. Predicate Devices: The NewPrim system is substantially equivalent to the primary predicate RTS Flexible 1st MPJ Implant w/ Grommets (K153609) and reference predicate Integra Classic Great Toe Implant (K023562). Substantial Equivalence: The NewPrim System and the legall… | 2016 |
| † | K023562 | Modification to Classic Great Toe Implant | 2002 |
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 42 years and passes through 4 companies; a new generation was cleared every 18.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K153609.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 BRM Extremities NewPrim device is intended for use in:
- Hallux rigidus or hallux limitus;
- 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/K191966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191966: NewPrim System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191966
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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