510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws

K113014510(k) TraditionalCleared Jan 31, 2012112-day reviewClass II21 CFR 888.3030Recalls 12

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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on Jan 31, 2012 as substantially equivalent to K102352 (Wrightmedicaltechnologyinc, 2010) and 8 other predicates after a 112-day review. Its family tree reaches back 8 generations to 1996. 97 later devices descend from it. It has been recalled 12 times.

Decided
Jan 31, 2012
Review
112 days
Class
Class II
Product code
HRS
Recalls
12
Predicates
9

Its longest line of descent runs back 8 generations to K954385 (1996). 47 ancestors in all, the oldest K895117 (1990). 97 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 3 other ancestors2009: 4 other ancestors2008: 1 other ancestor2005: 2 other ancestors2007: 1 other ancestor2006: 4 other ancestors2004: 1 other ancestor2002: 2 other ancestors1992: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors1996: 2 other ancestors1994: 3 other ancestors2000: 4 other ancestors1997: 2 other ancestors1995: 1 other ancestor1990: 2 other ancestors2020: 12 descendants cleared2012: 1 descendant cleared2022: 6 descendants cleared2015: 6 descendants cleared2014: 3 descendants cleared2019: 6 descendants cleared2016: 4 descendants cleared2017: 9 descendants cleared2023: 11 descendants cleared2018: 5 descendants cleared2024: 11 descendants cleared2021: 9 descendants cleared2025: 7 descendants cleared2026: 7 descendants clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 8 other ancestors3 generations back: 4 other ancestors4 generations back: 6 other ancestors5 generations back: 9 other ancestors6 generations back: 4 other ancestors7 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 13 descendants3 generations forward: 31 descendants4 generations forward: 22 descendants5 generations forward: 15 descendants6 generations forward: 8 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 2010K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996−50+5
  1. Root · 8 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 7 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 6 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 5 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 4 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 3 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. 2 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  8. 1 generation backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  9. This deviceK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012
  10. Descendant · cites it directly · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  11. Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  12. Descendant · 2 generations on · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
  13. Descendant · 2 generations on · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
  14. Descendant · 2 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2012: 12014: 32015: 62016: 42017: 92018: 52019: 62020: 122021: 92022: 62023: 112024: 112025: 72026: 7
2012high 12 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 97 · See all
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · cites it directly95descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
  • K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · 2 generations on24descendants
  • K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · 2 generations on23descendants
  • K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 2 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−7K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−6K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−5K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−4K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−3K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
−2K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
−1K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
0 (this device)K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc2012—
+1K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+2K143025Total Compression Plating SystemWrightmedicaltechnologyinc2014—
+2K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc2015—
+2K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199210
199430
199510
199620
199720
199920
200040
200130
200220
200410
200520
200640
200710
200810
200940
201030
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201430
201560
201640
201790
201850
201960
2020120
202190
202260
2023110
2024110
202570
202670
FIG. 1 — Lineage of K113014, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (9)

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
*K102352Evolve Eps Ortholoc
Summary page 1
…HRS: Plate, Fixation Bone 87 orthopedics (a)(3). Predicate Device: K 1023 52-EVOLVE® EPS ORTHOLOCTM System…
Wrightmedicaltechnologyinc2010—
*K051908Charlotte Compression Plate
Summary page 1
…K 1023 52-EVOLVE® EPS ORTHOLOCTM System K05 1908- CHARLOTTE® CLAW® Plating System…
Wrightmedicaltechnologyinc2005—
*K080295Charlotte Claw 3.5
Summary page 1
…K05 1908- CHARLOTTE® CLAW® Plating System K080295- CHARLOTTE® CLAW® 3.5 Plating System headquarters Wright Medical Tech…
Wrightmedicaltechnologyinc200810
*K093914Newdeal Compression Plates
Summary page 2
…Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com K0939 14- NEWDEAL® COMPRESSION PLATES…
Newdeal Sas20115
*K091614Osteomed Foot Plating System
Summary page 2
…K0939 14- NEWDEAL® COMPRESSION PLATES K091614-OSTEOMED FOOT PLATING SYSTEM…
Osteomed LP2009—
*K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…
Summary page 2
…K091614-OSTEOMED FOOT PLATING SYSTEM K101240-DEPUY ALPS SMALL BONE LOCKED PLATING SYSTEM…
DePuy Orthopaedics, Inc.2010—
*K083843Locking Anatomic & Composite Plating System
Summary page 2
…K101240-DEPUY ALPS SMALL BONE LOCKED PLATING SYSTEM K083843-LOCKJNG ANATOMIC & COMPOSITE PLATING SYSTEM…
DePuy Orthopaedics, Inc.20092
*K073624Modular Foot System
Summary page 2
…K083843-LOCKJNG ANATOMIC & COMPOSITE PLATING SYSTEM K073624-MODULAR FOOT SYSTEM K10061 8-MAXLOCK EXTREME@…
Orthohelix Surgical Designs, Inc.20081
*K100618Maxlock Extreme Extremity Plating System with Variable Angle Technology
Summary page 2
…OMPOSITE PLATING SYSTEM K073624-MODULAR FOOT SYSTEM K10061 8-MAXLOCK EXTREME@ EXTREMITY PLATING SYSTEM (a)(4). Device Description…
Orthohelix Surgical Designs, Inc.2010—

Also cleared against K102352: 3 other devices →

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295
K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 2, 2023Class IIZ-1169-2023Employee errorStryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly…
Feb 2, 2023Class IIZ-1170-2023Employee errorStryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly…
Dec 3, 2021Class IIZ-0392-2022Under Investigation by firmThe incorrect product is contained in the packaging.
Jul 30, 2014Class IIZ-2608-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2601-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2604-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2603-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2600-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2599-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2602-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2607-2014Device DesignPlates manufactured from an incorrect raw material.
Jul 30, 2014Class IIZ-2605-2014Device DesignPlates manufactured from an incorrect raw material.

The 5 latest of 12 recalls; the web page lists all.

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 2.0 years on median.
  • 11 of the 47 ancestors have a recall of any class.
  • Of its descendants, K121651 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 95 descendants of its own.
  • 3 other devices also cite its predicate K102352.

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 CLAW® 11 Polyaxial Compression Plating System is intended to be used for fixation such as:

* Midfoot and hindfoot arthrodeses or osteotomies

* Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)

* Intercuneiform arthrodeses

* Naviculocuneiform arthrodeses

* Talonavicular arthrodeses

* Calcaneocuboid arthrodeses

* Lisfranc arthrodeses

* Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot

* Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)

* Akin osteotomies

* First metatarsophalangeal arthrodeses

Indications for use as stated in the FDA summary.

Also cleared against K102352

3 other devices cite the same predicate.

  • K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc. · 2018
  • K113339Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2011
  • K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011

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311 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K113014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113014

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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