510(k) Report

510(k) · Cleared

Cleared

Ifs Bone Fixation Devices

K071035510(k) TraditionalCleared Aug 13, 2007123-day reviewClass II21 CFR 888.3040

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. · HWC Screw, Fixation, Bone

Cleared on Aug 13, 2007 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 7 other predicates after a 123-day review. Its family tree reaches back 6 generations to 1976. 3 later devices descend from it.

Decided
Aug 13, 2007
Review
123 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
8

Its longest line of descent runs back 6 generations to K761228 (1976). 40 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 4 other ancestors2001: 1 other ancestor1997: 4 other ancestors1996: 6 other ancestors2006: 1 other ancestor2000: 2 other ancestors1998: 2 other ancestors2004: 1 other ancestor1999: 3 other ancestors1994: 2 other ancestors1995: 3 other ancestors1991: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2014: 2 descendants cleared2025: 1 descendant clearedK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997×2: 2 generations cleared close together, K970912 (1997), K974785 (1998) K023260 · 1.2MM Osteomed Auto-Drive Screw System · Osteomed Corp. · 2002K063589 · Gso Bone Fixation Fasteners · Gold Standard Orthopaedics, LLC · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 12 other ancestors4 generations back: 11 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K063589 · Gso Bone Fixation Fasteners · Gold Standard Orthopaedics, LLC · 2007K023260 · 1.2MM Osteomed Auto-Drive Screw System · Osteomed Corp. · 2002K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−50
  1. Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 2 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
  6. 1 generation backK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
  7. This deviceK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
  8. Descendant · cites it directly · 1 of its ownK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
  9. Descendant · 2 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
  10. Descendant · cites it directly · 0 of its ownK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014 · cites it directly1descendant
  • K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 2 generations on0descendants
  • K140216Orthopedic Fixation SystemsImpact Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−5K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−4K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−3K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−2K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.2002—
−1K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC2007—
0 (this device)K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.2007—
+1K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga2014—
+2K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025—
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199010
199110
199420
199530
199660
199740
199820
199930
200020
200110
200410
200540
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
202510
FIG. 1 — Lineage of K071035, 1976–2025Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (8)

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
*K960385Sterile Kirschner Wires and Steinmann Pins
Summary page 1
…ion Number: 21 CFR 888.3040 Regulatory Class: II Device Product HWC Code: Substantially Depuy Kirschner Wires and Steinmann Pins (K960385) Equivalent Devices: Plus Cancellous Bone Screws (KO01719) Biodynamic Technologies, Inc. (K972403)…
Depuy, Inc.1996—
*K011719Plus Cancellous Bone Screws
Our reading of the summary gave K001719, FDA’s number for Q-Lux Plasma 100 Light Cure Unit (Rolence Enterprise Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plus Cancellous Bone Screws”.
Plus Orthopedics2001—
*K972403Bti Cortical Bone Screws
Summary page 1
…Depuy Kirschner Wires and Steinmann Pins (K960385) Equivalent Devices: Plus Cancellous Bone Screws (KO01719) Biodynamic Technologies, Inc. (K972403) GSO Bone Fixation Fasteners (K063589) Nexa Bone Screw System (K053394)…
Biodynamic Technologies, Inc.1997—
*K063589Gso Bone Fixation Fasteners
Summary page 1
…lent Devices: Plus Cancellous Bone Screws (KO01719) Biodynamic Technologies, Inc. (K972403) GSO Bone Fixation Fasteners (K063589) Nexa Bone Screw System (K053394) Synthes 3.5 Cortex Screws (K043185)…
Gold Standard Orthopaedics, LLC2007—
*K053394Nexa Bone Screw System
Summary page 1
…Biodynamic Technologies, Inc. (K972403) GSO Bone Fixation Fasteners (K063589) Nexa Bone Screw System (K053394) Synthes 3.5 Cortex Screws (K043185) Synthes 7.0/7.3 Cannulated Screws (K962011)…
Nexa Orthopedics, Inc.2005—
*K043185Synthes 3.5MM Cortex Screws
Summary page 1
…3) GSO Bone Fixation Fasteners (K063589) Nexa Bone Screw System (K053394) Synthes 3.5 Cortex Screws (K043185) Synthes 7.0/7.3 Cannulated Screws (K962011) OsteoMed 1.2mm Auto-Drive Screw System…
Synthes (Usa)2005—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…Nexa Bone Screw System (K053394) Synthes 3.5 Cortex Screws (K043185) Synthes 7.0/7.3 Cannulated Screws (K962011) OsteoMed 1.2mm Auto-Drive Screw System (K023260) Device Description: The IFS Bone Fixation Devices co…
Synthes (Usa)1996—
*K0232601.2MM Osteomed Auto-Drive Screw System
Summary page 1
…Synthes 3.5 Cortex Screws (K043185) Synthes 7.0/7.3 Cannulated Screws (K962011) OsteoMed 1.2mm Auto-Drive Screw System (K023260) Device Description: The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screw…
Osteomed Corp.2002—

Also cleared against K960385: 16 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141
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 31 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
  • 1 of the 40 ancestors has a recall of any class.
  • Of its descendants, K130613 (Laura Cattabriga, 2014) has gone furthest, with 1 descendant of its own.
  • 16 other devices also cite its predicate K960385.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

***Warning: IFS Bone Fixation Devices are not indicated for spinal fixation,***

Indications for use as stated in the FDA summary.

Also cleared against K960385

16 other devices cite the same predicate.

  • K203605SteriTrakArbutus Medical, Inc. · 2021
  • K173910Impress SFS SystemCable Fix Medical, LLC · 2018
  • K181425APTUS® Proximal Humerus SystemMedartis AG · 2018
  • K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017
  • K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG · 2013
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls

More from Internal Fixation Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K113399Ifs Subtalar ImplantInternal Fixation Systems, Inc. · 2011
  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K071035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071035: Ifs Bone Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071035

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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