510(k) · Cleared
ClearedProfyle Titanium Hand and Small Fragment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 28, 1996 after a 71-day review. The FDA summary names its predicate without a number. 628 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
628 later devices descend from it, 9 citing it directly.
- This deviceK961497 Profyle Titanium Hand and Small Fragment SystemHowmedica, Inc. · 1996
- Descendant · cites it directly · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 2 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 3 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · cites it directly · 280 of its ownK021626 Hallu PlatesNew Deal, S.A. · 2002
Showing 5 of 628 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 628 · See all- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · cites it directly360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 2 generations on343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 3 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 4 generations on339descendants
- K021626Hallu PlatesNew Deal, S.A. · 2002 · cites it directly280descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961497 | Profyle Titanium Hand and Small Fragment System | Howmedica, Inc. | 1996 | — |
| +1 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +2 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +3 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +1 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 24 | 0 |
| 2013 | 23 | 0 |
| 2014 | 32 | 0 |
| 2015 | 40 | 0 |
| 2016 | 25 | 0 |
| 2017 | 55 | 0 |
| 2018 | 31 | 0 |
| 2019 | 33 | 0 |
| 2020 | 42 | 0 |
| 2021 | 33 | 0 |
| 2022 | 40 | 0 |
| 2023 | 46 | 0 |
| 2024 | 63 | 0 |
| 2025 | 44 | 0 |
| 2026 | 53 | 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 |
|---|---|---|---|
| * | — | Luhr® Fixation System Named without a submission number | |
| * | — | Synthes® Small Fragment and Mini Set Named without a submission number | |
| * | — | Wurzburg° Titanium Mini Bone Plates and Screws Named without a submission number |
What descends from it? (628)
See all 6289 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040598 | KLS Martin Hand Plating System | 2004 | 360 |
| K021626 | Hallu Plates | 2002 | 280 |
| K040907 | Arthrex Small Fragment Plates and Screws | 2004 | 249 |
| K051567 | Aptus Titanium Osteosynthesis System | 2005 | 157 |
| K062498 | Profyle System | 2006 | 81 |
| K032534 | Synthes Afs | 2004 | 43 |
| K142418 | I.T.S. Hand Locking Plates System - HLS | 2014 | 1 |
| K111266 | Easylock Osteosystem | 2011 | 0 |
| K071797 | Mondeal Hand Contour System | 2007 | 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?
- Of its descendants, K040598 (KLS-Martin L.P., 2004) has gone furthest, with 360 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.
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 system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton.
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/K961497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961497: Profyle Titanium Hand and Small Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961497
Report an extraction error
Are you the manufacturer?
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