510(k) · Cleared
ClearedBPS - Bone Fragment Fixation Plates, Screws and Washers
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 Feb 6, 2025 as substantially equivalent to K130614 (Laura Cattabriga, 2014) and 2 other predicates after a 27-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Feb 6, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K000684 (2000). 61 ancestors in all, the oldest K882831 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 2 generations backK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
- 1 generation backK130614 Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014
- This deviceK250055 BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −4 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −3 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −2 | K110086 | Ifs Profile Plates, Screws, and Washers | Internal Fixation Systems, Inc. | 2011 | — |
| −1 | K130614 | Bone Fragment and Fixation Plates, Screws and Washers | Laura Cattabriga | 2014 | — |
| 0 (this device) | K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | 2025 | — |
| +1 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K130614 | Bone Fragment and Fixation Plates, Screws and WashersSummary page 5…Product Code(s) HRS, HWC, HTN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K130614 BONE FRAGMENT AND FIXATION PLATES, SCREWS AND W | HRS K110086 IFS Bone Plates, Screws, and Washers HRS K113733 Small and Large Fr… | 2014 |
| * | K110086 | Ifs Profile Plates, Screws, and WashersSummary page 5…vices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K130614 BONE FRAGMENT AND FIXATION PLATES, SCREWS AND W | HRS K110086 IFS Bone Plates, Screws, and Washers HRS K113733 Small and Large Fragments Osteosynthesis System NEOFIX HRS Device Description Su… | 2011 |
| * | K113733 | Small and Large Fragments Osteosynthesis System NeofixSummary page 5…rade Name (Primary Predicate is listed first) Product Code K130614 BONE FRAGMENT AND FIXATION PLATES, SCREWS AND W | HRS K110086 IFS Bone Plates, Screws, and Washers HRS K113733 Small and Large Fragments Osteosynthesis System NEOFIX HRS Device Description Summary 21 CFR 807.92(a)(4) The bone fragment fixa… | 2012 |
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 |
|---|---|---|---|
| K252758 | Cannulated Screw and Kirschner (K wire) System | 2025 | 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 25 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 61 ancestors have a recall of any class.
- Of its descendants, K252758 (Orthonovis, Inc., 2025) has gone furthest, with 0 descendants of its own.
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 OrthoNovis bones plates and screws system are intended to be used for internal fixation of
bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long
bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals,
metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the
cortex of the bone by distributing the forces/load over a large area when used for fracture fixation
of large bone and bone fragments.
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/K250055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250055
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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