510(k) · Cleared
ClearedBPS Wrist Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthonovis, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 17, 2025 as substantially equivalent to K242343 (Orthonovis, Inc., 2024) and 1 other predicate after a 25-day review. Its family tree reaches back 18 generations to 1979.
- Decided
- Mar 17, 2025
- Review
- 25 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K792022 (1979). 147 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 14 generations between
- 3 generations backK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
- 2 generations backK233919 VariAx 2 Distal Radius SystemStryker GmbH · 2024
- 1 generation backK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
- This deviceK250498 BPS Wrist Fracture SystemOrthonovis, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 17 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 16 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 15 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 14 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 13 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 12 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 11 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 10 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 9 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 8 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 7 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 6 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 5 generations backK180500 VariAx 2 SystemStryker GmbH · 2018
- 4 generations backK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- 3 generations backK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
- 2 generations backK233919 VariAx 2 Distal Radius SystemStryker GmbH · 2024
- 1 generation backK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
- This deviceK250498 BPS Wrist Fracture SystemOrthonovis, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −17 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −16 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −15 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −14 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −13 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −12 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −11 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −10 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −9 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −8 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −7 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −6 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| −5 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| −4 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| −3 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | 2022 | — |
| −2 | K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 2024 | — |
| −1 | K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024 | — |
| 0 (this device) | K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K242343 | BPS Wrist Fracture SystemSummary page 5…030 Product Code(s) HRS, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K242343 BPS Wrist Fracture System HRS K191641 AFFINITY Variable Angle Distal Radius System HRS | Device Description Summary 21 CFR 807.9… | 2024 |
| * | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Summary page 5…y Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K242343 BPS Wrist Fracture System HRS K191641 AFFINITY Variable Angle Distal Radius System HRS | Device Description Summary 21 CFR 807.92(a)(4) The BPS Wrist Fracture System… | 2019 |
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 46 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 28 of the 147 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults.
The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
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/K250498 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250498: BPS Wrist Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250498
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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