510(k) Report

510(k) · Cleared

Cleared

May Humerus Plates

K912936510(k) TraditionalCleared Sep 6, 199163-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

Turnkey Intergration USA, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 6, 1991 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 803 devices in its family, counting itself, has a Class I recall. 802 later devices descend from it.

Decided
Sep 6, 1991
Review
63 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

802 later devices descend from it, 3 citing it directly. 1 of the 803 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2018: 31 descendants cleared2001: 1 descendant cleared2010: 10 descendants cleared2004: 3 descendants cleared2014: 40 descendants cleared2002: 3 descendants cleared2008: 4 descendants cleared2013: 24 descendants cleared2012: 21 descendants cleared2005: 12 descendants cleared2006: 9 descendants cleared2011: 21 descendants cleared2017: 62 descendants cleared2024: 74 descendants cleared2007: 8 descendants cleared2003: 1 descendant cleared2009: 7 descendants cleared2025: 70 descendants cleared2015: 43 descendants cleared2026: 83 descendants cleared2022: 48 descendants cleared2021: 52 descendants cleared, 1 with a Class I recall12019: 41 descendants cleared2020: 50 descendants cleared2023: 56 descendants cleared2016: 27 descendants cleared1990200020102020
  1. This deviceK912936 May Humerus PlatesTurnkey Intergration USA, Inc. · 1991
  2. Descendant · cites it directly · 792 of its ownK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. Descendant · 3 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  5. Descendant · 4 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  6. Descendant · 2 generations on · 280 of its ownK021626 Hallu PlatesNew Deal, S.A. · 2002

Showing 5 of 802 descendants. See all descendants

Descendants cleared per year

1997: 12001: 12002: 32003: 12004: 32005: 122006: 92007: 82008: 42009: 72010: 102011: 212012: 212013: 242014: 402015: 432016: 272017: 622018: 312019: 412020: 502021: 522022: 482023: 562024: 742025: 702026: 83
1997high 83 (2026) · low 0 (1998)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 802 · See all
  • K012655Congruent Bone Plate SystemAcu Med, Inc. · 2001 · cites it directly792descendants
  • K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
  • K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 3 generations on495descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 4 generations on487descendants
  • K021626Hallu PlatesNew Deal, S.A. · 2002 · 2 generations on280descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912936May Humerus PlatesTurnkey Intergration USA, Inc.1991—
+1K012655Congruent Bone Plate SystemAcu Med, Inc.200116
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
+4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+2K021626Hallu PlatesNew Deal, S.A.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200230
200310
200430
2005120
200690
200780
200840
200970
2010100
2011210
2012210
2013240
2014400
2015430
2016270
2017620
2018310
2019410
2020500
2021521
2022480
2023560
2024740
2025700
2026830
FIG. 1 — Lineage of K912936, 1991–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (802)

See all 802

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

NumberDeviceApplicantDecidedDescendants
K012655Congruent Bone Plate SystemAcu Med, Inc.2001792
K972219Orthopedic Plate SystemFerguson Medical19978
K171372Alians Elbow Locking Plating SystemNewclip Technics20180

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K012655 (Acu Med, Inc., 2001) has gone furthest, with 792 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Turnkey Intergration USA, Inc.

26 FDA decisions under this applicant name. See the company

  • K991405Omni-Fix, Humeral NailTurnkey Intergration USA, Inc. · 1999
  • K990523B2C, Espace Revision Cup SystemTurnkey Intergration USA, Inc. · 1999
  • K990307Omni-Fix, Nail SystemTurnkey Intergration USA, Inc. · 1999
  • K972411Link Cement PlugTurnkey Intergration USA, Inc. · 1997
  • K970284Artos, Diplos SystemTurnkey Intergration USA, Inc. · 1997

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/K912936 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912936: May Humerus Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912936

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026