510(k) Report

510(k) · Cleared

Cleared

Checkmate Small Bone Fusion System

K122334510(k) TraditionalCleared Nov 28, 2012118-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrosurface, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 28, 2012 as substantially equivalent to K111253 (Arthrex, Inc., 2011) and 4 other predicates after a 118-day review. Its family tree reaches back 9 generations to 1996. 5 later devices descend from it.

Decided
Nov 28, 2012
Review
118 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
5

Its longest line of descent runs back 9 generations to K962616 (1996). 72 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2007: 1 other ancestor2006: 5 other ancestors2005: 7 other ancestors2009: 1 other ancestor2003: 2 other ancestors2001: 7 other ancestors1996: 8 other ancestors2010: 1 other ancestor2000: 6 other ancestors1999: 2 other ancestors1990: 1 other ancestor2004: 4 other ancestors2002: 5 other ancestors1998: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1979: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2016: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors3 generations back: 17 other ancestors4 generations back: 21 other ancestors5 generations back: 8 other ancestors6 generations back: 1 other ancestor8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  5. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  6. This deviceK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012
  7. Descendant · cites it directly · 4 of its ownK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
  8. Descendant · cites it directly · 2 of its ownK161539 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2016
  9. Descendant · 2 generations on · 1 of its ownK172383 Arthrosurface Bone ScrewsArthrosurface, Inc. · 2017
  10. Descendant · 3 generations on · 0 of its ownK200226 RetroFixRetrofix Screws, LLC · 2020
  11. Descendant · 2 generations on · 0 of its ownK162391 AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc. · 2017
Show all 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 1 generation backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. This deviceK122334 Checkmate Small Bone Fusion SystemArthrosurface, Inc. · 2012

Most influential descendants

Showing 5 of 5 · See all
  • K140617Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014 · cites it directly4descendants
  • 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 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
0 (this device)K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.2012—
+1K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.2014—
+1K161539Arthrosurface Bone ScrewsArthrosurface, Inc.2016—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.2017—
+3K200226RetroFixRetrofix Screws, LLC2020—
+2K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199320
199420
199520
199680
199820
199920
200060
200170
200250
200320
200440
200570
200650
200710
200910
201010
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
201720
202010
FIG. 1 — Lineage of K122334, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K111253Arthrex Distal Extremity Plate System
Summary page 2
…ce are substantially equivalent to the following previously cleared and commercially marketed devices: " Arthrex, Inc. K1 11253 Distal Extremity Plate System * Smith & Nephew K090675 VLP Foot Pla…
Arthrex, Inc.2011—
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 2
…threx, Inc. K1 11253 Distal Extremity Plate System * Smith & Nephew K090675 VLP Foot Plating, Screw System and Accessories * Synthes(USA) K071264…
Smith & Nephew, Inc.2009—
*K071264Synthes (Usa) 2.4/2.7 MM Locking Foot Module
Summary page 2
…K090675 VLP Foot Plating, Screw System and Accessories * Synthes(USA) K071264 K063049 Synthes (USA) 2.4/2.7 mm Locking Foot Module…
Synthes (Usa)2007—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 2
…Screw System and Accessories * Synthes(USA) K071264 K063049 Synthes (USA) 2.4/2.7 mm Locking Foot Module Synthes (USA) Modular Mini Fragment LCP System " Wright Medical Te…
Synthes (Usa)20064
*K051908Charlotte Compression Plate
Summary page 2
…Synthes (USA) 2.4/2.7 mm Locking Foot Module Synthes (USA) Modular Mini Fragment LCP System " Wright Medical Technology, Inc. K051 908 Charlotte TM Compression Plate Comparative static and dynamic four-point bending test results, along with comparative dim…
Wrightmedicaltechnologyinc2005—

Also cleared against K111253: 9 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144
K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162

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 16 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • 18 of the 72 ancestors have a recall of any class.
  • Of its descendants, K140617 (Arthrosurface, Inc., 2014) has gone furthest, with 4 descendants of its own.
  • 9 other devices also cite its predicate K111253.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The CheckMateTM Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Indications for use as stated in the FDA summary.

Also cleared against K111253

9 other devices cite the same predicate.

  • K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. · 2026
  • K201132Arthrex Compression ScrewsArthrex, Inc. · 2020
  • K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc. · 2020
  • K170547Arthrex Mesh Plate SystemArthrex, Inc. · 2017
  • K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

More from Arthrosurface, Inc.

26 FDA decisions under this applicant name. See the company

  • K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 2021
  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
  • K190261BOSS Toe Fixation SystemArthrosurface, Inc. · 2019
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K122334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122334: Checkmate 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/K122334

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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