510(k) Report

510(k) · Cleared

Cleared

Ifs Profile Plates, Screws, and Washers

K110086510(k) TraditionalCleared Sep 9, 2011240-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

Internal Fixation Systems, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 9, 2011 as substantially equivalent to K052614 (Arthrex, Inc., 2005) and 9 other predicates after a 240-day review. Its family tree reaches back 6 generations to 2000. 5 later devices descend from it.

Decided
Sep 9, 2011
Review
240 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
10

Its longest line of descent runs back 6 generations to K000684 (2000). 30 ancestors in all, the oldest K882831 (1988). 5 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2008: 3 other ancestors2007: 2 other ancestors2006: 3 other ancestors2005: 1 other ancestor2002: 2 other ancestors1991: 2 other ancestors1988: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors1996: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1989: 1 other ancestor2014: 2 descendants cleared2015: 1 descendant cleared2025: 2 descendants clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K021626 · Hallu Plates · New Deal, S.A. · 2002K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 4 other ancestors3 generations back: 6 other ancestors4 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K021626 · Hallu Plates · New Deal, S.A. · 2002K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50
  1. Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
  5. 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  6. 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
  7. This deviceK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
  8. Descendant · cites it directly · 2 of its ownK130614 Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014
  9. Descendant · cites it directly · 1 of its ownK250055 BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025
  10. Descendant · 2 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
  11. Descendant · cites it directly · 0 of its ownK143721 PRCT2Fx Solutions · 2015
  12. Descendant · cites it directly · 0 of its ownK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014

Most influential descendants

Showing 5 of 5 · See all
  • K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014 · cites it directly2descendants
  • K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025 · cites it directly1descendant
  • K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 2 generations on0descendants
  • K143721PRCT2Fx Solutions · 2015 · cites it directly0descendants
  • K140216Orthopedic Fixation SystemsImpact Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−5K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−4K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−3K021626Hallu PlatesNew Deal, S.A.2002—
−2K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—
−1K052614Low Profile Plate and Screw SystemArthrex, Inc.2005—
0 (this device)K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.2011—
+1K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga2014—
+1K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.2025—
+2K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025—
+1K143721PRCT2Fx Solutions2015—
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199120
199410
199510
199610
199820
200010
200110
200220
200510
200630
200720
200830
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201510
202520
FIG. 1 — Lineage of K110086, 2000–2025Source: 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? (10)

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
*K052614Low Profile Plate and Screw System
Summary page 1
…CER 888.3040: Smooth or threaded metallic bone fixation fastener (HWC) Predicate Devices: * Arthrex Low Profile Plate and Screw System (K0526 14) * Synthes Calcaneal Plate (K020401) * GPC Medical Bone Plates and Screws…
Arthrex, Inc.2005—
*K020401Synthes Calcaneal Plate
Summary page 1
…(HWC) Predicate Devices: * Arthrex Low Profile Plate and Screw System (K0526 14) * Synthes Calcaneal Plate (K020401) * GPC Medical Bone Plates and Screws (K092493) * Synthes USA Modular Min…
Synthes (Usa)2002—
*K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System
Summary page 1
…ofile Plate and Screw System (K0526 14) * Synthes Calcaneal Plate (K020401) * GPC Medical Bone Plates and Screws (K092493) * Synthes USA Modular Mini Fragment LCP System (K063049) * Synthes USA 1…
Gpc Medical, Ltd.2010—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 1
…al Plate (K020401) * GPC Medical Bone Plates and Screws (K092493) * Synthes USA Modular Mini Fragment LCP System (K063049) * Synthes USA 1.5 Mini Fragment LCP System (K090047) * Synthes USA 2.4/2…
Synthes (Usa)20064
*K090047Synthes (Usa) 1.5MM Mini Fragment LCP System
Summary page 1
…ws (K092493) * Synthes USA Modular Mini Fragment LCP System (K063049) * Synthes USA 1.5 Mini Fragment LCP System (K090047) * Synthes USA 2.4/2.7 Locking Foot Module (K07l264) *Depuy Orthopaedlics…
Synthes (Usa)2009—
*K071264Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSynthes (Usa)2007—
*K072083Small Fragment Locking Plating System
Summary page 1
…* Synthes USA 2.4/2.7 Locking Foot Module (K07l264) *Depuy Orthopaedlics Small Fragment Locking Plating System (K072083) * Depuy Orthopaedics Small Bone Locking Plate System (K(08 1546)…
DePuy Orthopaedics, Inc.20072
*K081546Small Bone Locking Plating SystemDePuy Orthopaedics, Inc.20081
*K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws
Summary page 1
…ystem (K(08 1546) * Zimmer Inc. Universal Locking System 3.5mmn Plates and Screws (K082 527) * Synthes Spherical Washers (K052483) Device Description: IFS bone plates consists of various sha…
Zimmer, Inc.20085
*K052483Synthes (Usa) Spherical Washers
Summary page 1
…* Zimmer Inc. Universal Locking System 3.5mmn Plates and Screws (K082 527) * Synthes Spherical Washers (K052483) Device Description: IFS bone plates consists of various shapes as well as screws are intended to trea…
Synthes (Usa)2005—

Also cleared against K052614: 12 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142
K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251
K143721PRCT2Fx Solutions20150
K140216Orthopedic Fixation SystemsImpact Medical, LLC20140

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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 10 of the 30 ancestors have a recall of any class.
  • Of its descendants, K130614 (Laura Cattabriga, 2014) has gone furthest, with 2 descendants of its own.
  • 12 other devices also cite its predicate K052614.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.

The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K052614

12 other devices cite the same predicate.

  • K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical · 2024
  • K232105APTUS Foot System 2.8-3.5Medartis AG · 2024
  • K193639APTUS® Foot 2.8-3.5 SystemMedartis AG · 2020
  • K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017
  • K151456Small Bone Nail ImplantVilex IN Tennessee, Inc. · 2015
  • K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC · 2015

More from Internal Fixation Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K113399Ifs Subtalar ImplantInternal Fixation Systems, Inc. · 2011
  • K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006

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/K110086 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110086: Ifs Profile Plates, Screws, and Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110086

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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