510(k) · Cleared
ClearedPinit Small Bone Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 25, 2014 as substantially equivalent to K122334 (Arthrosurface, Inc., 2012) and 2 other predicates after a 45-day review. Its family tree reaches back 10 generations to 1996. 4 later devices descend from it.
- Decided
- Apr 25, 2014
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K962616 (1996). 82 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012
- This deviceK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK161539 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK172383 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK200226 RetroFixRetrofix Screws, LLC · 2020
- Descendant · cites it directly · 0 of its ownK162391 AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012
- This deviceK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K161539Arthrosurface Bone ScrewsArthrosurface, Inc. · 2016 · cites it directly2descendants
- K172383Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017 · 2 generations on1descendant
- K200226RetroFixRetrofix Screws, LLC · 2020 · 3 generations on0descendants
- K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K122334 | Checkmate Small Bone Fusion System | Arthrosurface, Inc. | 2012 | — |
| 0 (this device) | K140617 | Pinit Small Bone Fusion System | Arthrosurface, Inc. | 2014 | — |
| +1 | K161539 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2016 | — |
| +2 | K172383 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2017 | — |
| +3 | K200226 | RetroFix | Retrofix Screws, LLC | 2020 | — |
| +1 | K162391 | AlignMATE™ Lapidus Arthrodesis System | Arthrosurface, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 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 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 |
|---|---|---|---|
| * | K122334 | Checkmate Small Bone Fusion SystemSummary page 2…uivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA: CheckMate T M Small Bone Fusion System (K1 22334, Cleared on 11 /28/2012) Aptus® 1.5 TniLock (K1 02537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907,… | 2012 |
| * | K102537 | Aptus 1.5 TrilockSummary page 2…ollowing predicate devices, which have been previously cleared by the FDA: CheckMate T M Small Bone Fusion System (K1 22334, Cleared on 11 /28/2012) Aptus® 1.5 TniLock (K1 02537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907, Cleared on 07/01/2004) The fundamental scientific tec… | 2010 |
| * | K040907 | Arthrex Small Fragment Plates and ScrewsSummary page 2…CheckMate T M Small Bone Fusion System (K1 22334, Cleared on 11 /28/2012) Aptus® 1.5 TniLock (K1 02537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907, Cleared on 07/01/2004) The fundamental scientific technology of the proposed device has not changed relative to the predicate d… | 2004 |
What descends from it? (4)
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 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 21 of the 82 ancestors have a recall of any class.
- Of its descendants, K161539 (Arthrosurface, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122334.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Well), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140617: Pinit Small Bone Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140617
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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