510(k) Report

510(k) · Cleared

Cleared

Scarf Thread-Head Screw

K962236510(k) TraditionalCleared Sep 20, 1996101-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

Landos, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 20, 1996 as substantially equivalent to K931155 (Roseburg SA, 1994) and 3 other predicates after a 101-day review. Its family tree reaches back 1 generation to 1979. 1 of the 553 devices in its family, counting itself, has a Class I recall. 548 later devices descend from it.

Decided
Sep 20, 1996
Review
101 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K792022 (1979). 4 ancestors in all. 548 later devices descend from it, 3 citing it directly. 1 of the 553 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1993: 2 other ancestors2006: 1 descendant cleared2007: 2 descendants cleared2009: 2 descendants cleared2014: 23 descendants cleared2015: 33 descendants cleared2013: 10 descendants cleared2012: 14 descendants cleared2022: 38 descendants cleared2017: 41 descendants cleared2011: 9 descendants cleared2010: 3 descendants cleared2023: 43 descendants cleared2018: 22 descendants cleared2021: 45 descendants cleared, 1 with a Class I recall12025: 54 descendants cleared2019: 29 descendants cleared2026: 70 descendants cleared2020: 36 descendants cleared2016: 15 descendants cleared2024: 58 descendants clearedK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 13 descendants3 generations forward: 53 descendants4 generations forward: 122 descendants5 generations forward: 145 descendants6 generations forward: 111 descendants, 1 with a Class I recall17 generations forward: 44 descendants8 generations forward: 31 descendants9 generations forward: 16 descendants10 generations forward: 7 descendants11 generations forward: 2 descendants12 generations forward: 1 descendant K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0+5+10
  1. Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. This deviceK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
  3. Descendant · cites it directly · 527 of its ownK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
  4. Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. Descendant · 3 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  6. Descendant · 3 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  7. Descendant · 4 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011

Showing 5 of 548 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22009: 22010: 32011: 92012: 142013: 102014: 232015: 332016: 152017: 412018: 222019: 292020: 362021: 452022: 382023: 432024: 582025: 542026: 70
2006high 70 (2026) · low 0 (2008)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 548 · See all
  • K062352FRS ScrewDePuy Orthopaedics, Inc. · 2006 · cites it directly527descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 3 generations on228descendants
  • K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 3 generations on161descendants
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 4 generations on118descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792022Herbert Bone ScrewZimmer, Inc.19796
0 (this device)K962236Scarf Thread-Head ScrewLandos, Inc.1996—
+1K062352FRS ScrewDePuy Orthopaedics, Inc.2006—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200920
201030
201190
2012140
2013100
2014230
2015330
2016150
2017410
2018220
2019290
2020360
2021451
2022380
2023430
2024580
2025540
2026700
FIG. 1 — Lineage of K962236, 1979–2026Source: 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), 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.

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 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
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What was it cleared against? (4)

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
*K931155Staple, Fixation Bone; Screw Fixation Bone
Summary page 2
…tomies of the mid-foot bones and the metatarsal and phalanges of the foot only. The SCARF THREAD-HEAD™ SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138). Both the SCARF THREAD-…
Roseburg SA1994—
*K792022Herbert Bone Screw
Summary page 2
…phalanges of the foot only. The SCARF THREAD-HEAD™ SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138). Both the SCARF THREAD-HEAD™ SCREW, the Scarf Screw and the Herbert-Whippl…
Zimmer, Inc.19796
*K924018M3 Lag Screw Fixation System
Summary page 2
…D-HEAD™ SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138). Both the SCARF THREAD-HEAD™ SCREW, the Scarf Screw and the Herbert-Whipple Bone Screw have the same intended use and a…
Osteomed Corp.1993—
*K924138Osteomed M3 System (SBF System)
Summary page 2
…CREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138). Both the SCARF THREAD-HEAD™ SCREW, the Scarf Screw and the Herbert-Whipple Bone Screw have the same intended use and all are i…
Osteomed Corp.1993—

Also cleared against K931155: 2 other devices →

What descends from it? (548)

See all 548

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

NumberDeviceApplicantDecidedDescendants
K062352FRS ScrewDePuy Orthopaedics, Inc.2006527
K070039Memometal Fixos ScrewsMemometal Technologies200784
K070617Cannulated ScrewFournitures Hospitalieres Industrie20074

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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K062352 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 527 descendants of its own.
  • 2 other devices also cite its predicate K931155.

How does its category compare?

All HWC devices

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

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 SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

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 K931155

2 other devices cite the same predicate.

  • K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC · 2018
  • K990622Bold ScrewNew Deal, S.A. · 19991 recall

More from Landos, Inc.

15 FDA decisions under this applicant name. See the company

  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 1997
  • K97106834MM Scarf Thread-Head (TM) ScrewLandos, Inc. · 1997
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
  • K961732KARLandos, Inc. · 1997

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/K962236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962236: Scarf Thread-Head Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962236

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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