510(k) Report

510(k) · Cleared

Cleared

Little Grafter Screw

K040265510(k) TraditionalCleared May 28, 2004113-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

Biocomposites, Ltd. · HWC Screw, Fixation, Bone

Cleared on May 28, 2004 as substantially equivalent to K792022 (Zimmer, Inc., 1979) and 4 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1979. 1 later device descends from it.

Decided
May 28, 2004
Review
113 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K792022 (1979). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1995: 3 other ancestors1993: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors2008: 1 descendant clearedK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K020222 · Wisorb Malleolar Screw · Cambridge Scientific, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant K020222 · Wisorb Malleolar Screw · Cambridge Scientific, Inc. · 2002K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0
  1. Root · 3 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 2 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
  3. 1 generation backK020222 Wisorb Malleolar ScrewCambridge Scientific, Inc. · 2002
  4. This deviceK040265 Little Grafter ScrewBiocomposites, Ltd. · 2004
  5. Descendant · cites it directly · 0 of its ownK073312 Osteotrans-OT ScrewTakiron Co., Ltd. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K073312Osteotrans-OT ScrewTakiron Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K792022Herbert Bone ScrewZimmer, Inc.19796
−2K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998—
−1K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.2002—
0 (this device)K040265Little Grafter ScrewBiocomposites, Ltd.2004—
+1K073312Osteotrans-OT ScrewTakiron Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199530
199620
199710
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K040265, 1979–2008Source: 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 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? (5)

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
*K792022Herbert Bone Screw
Summary page 1
…Smooth or threaded bone fixation fastener (3) Legally marketed predicate device: Herbert Bone Screw (Zimmer Inc) K792022 Acutrak (Acumned Inc) K944330 Asnis III Screw (Howmedica Osteonics)…
Zimmer, Inc.19796
*K944330Acutrak Plus Fixation System
Summary page 1
…Legally marketed predicate device: Herbert Bone Screw (Zimmer Inc) K792022 Acutrak (Acumned Inc) K944330 Asnis III Screw (Howmedica Osteonics) K000080 Synthes Compression Screw (Synthes USA)…
Acu Med, Inc.1995—
*K000080Asnis Iii Cannulated Screw System
Summary page 1
…c) K792022 Acutrak (Acumned Inc) K944330 Asnis III Screw (Howmedica Osteonics) K000080 Synthes Compression Screw (Synthes USA) K02 1556 Wisorb Malleolar Screw (Cambridge Scientific)…
Howmedica Osteonics Corp.20001
*K021556Synthes 2.4 MM Cannulated Compression Screw
Summary page 1
…K944330 Asnis III Screw (Howmedica Osteonics) K000080 Synthes Compression Screw (Synthes USA) K02 1556 Wisorb Malleolar Screw (Cambridge Scientific) K020222 (4) Subject device description: The Little Grafte…
Synthes (Usa)2002—
*K020222Wisorb Malleolar Screw
Summary page 1
…eonics) K000080 Synthes Compression Screw (Synthes USA) K02 1556 Wisorb Malleolar Screw (Cambridge Scientific) K020222 (4) Subject device description: The Little Grafter TM Screwv is a cannulated, sterile, single use bone fixation screw ma…
Cambridge Scientific, Inc.2002—

Also cleared against K792022: 17 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080

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 25 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K073312 (Takiron Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
  • 17 other devices also cite its predicate K792022.

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 Little Grafter TM Screw is indicated for fixation of fractures of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Indications for use as stated in the FDA summary.

Also cleared against K792022

17 other devices cite the same predicate.

  • K083144Acumed Clavicle Screw SystemAcumed, LLC · 2009
  • K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45Arex USA · 2008
  • K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
  • K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 2006
  • K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
  • K050924Merete Duothreadtm Bone ScrewMerete Medical GmbH · 2005

More from Biocomposites, Ltd.

27 FDA decisions under this applicant name. See the company

  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026
  • K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd. · 2025
  • K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd. · 2025
  • K212721Genex Bone Graft SubstituteBiocomposites, Ltd. · 2022
  • K141830Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 20151 recall

Recent decisions in HWC

The HWC category page

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  • 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/K040265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040265: Little Grafter Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040265

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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