510(k) Report

510(k) · Cleared

Cleared

2-Piece Hammertoe Correction System

K162685510(k) TraditionalCleared Jun 9, 2017256-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

Life Spine, Inc. · HWC Screw, Fixation, Bone

Cleared on Jun 9, 2017 as substantially equivalent to K130859 (Arthrosurface, Inc., 2013) and 6 other predicates after a 256-day review. Its family tree reaches back 8 generations to 1992.

Decided
Jun 9, 2017
Review
256 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
7

Its longest line of descent runs back 8 generations to K915818 (1992). 62 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2014: 3 other ancestors2013: 2 other ancestors2005: 1 other ancestor2002: 5 other ancestors1999: 2 other ancestors2012: 4 other ancestors2011: 2 other ancestors2010: 1 other ancestor2007: 2 other ancestors1998: 1 other ancestor1996: 5 other ancestors1991: 2 other ancestors2008: 1 other ancestor2003: 2 other ancestors2001: 5 other ancestors2000: 3 other ancestors1997: 1 other ancestor2006: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors1979: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1980: 1 other ancestor1989: 1 other ancestorK915818 · Synthes (R) Titanium Small Reconstruction Plate · Synthes (Usa) · 1992 · recalledK990094 · Kmi Wrist Fusion System · Kinetikos Medical, Inc. · 1999K991873 · Kmi Wrist Fusion System · Kinetikos Medical, Inc. · 1999K021321 · Wrist Fusion Plate · Acu Med, Inc. · 2002K050681 · Omnitech System & Easy Lock Osteosystem with Xtremities Plates · TriMed, Inc. · 2005K092670 · Biodrive Micro Screw System · Ebi,Llc D/B/A Biomet Trauma · 2009K150126 · Life Spine Cannulated Screws · Life Spine, Inc. · 2015K153065 · The Hammertoe Correction System · Life Spine, Inc. · 20161980199020002010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 8 other ancestors3 generations back: 8 other ancestors4 generations back: 6 other ancestors5 generations back: 10 other ancestors6 generations back: 9 other ancestors7 generations back: 6 other ancestors8 generations back: 1 other ancestor K153065 · The Hammertoe Correction System · Life Spine, Inc. · 2016K150126 · Life Spine Cannulated Screws · Life Spine, Inc. · 2015K092670 · Biodrive Micro Screw System · Ebi,Llc D/B/A Biomet Trauma · 2009K050681 · Omnitech System & Easy Lock Osteosystem with Xtremities Plates · TriMed, Inc. · 2005K021321 · Wrist Fusion Plate · Acu Med, Inc. · 2002K991873 · Kmi Wrist Fusion System · Kinetikos Medical, Inc. · 1999K990094 · Kmi Wrist Fusion System · Kinetikos Medical, Inc. · 1999K915818 · Synthes (R) Titanium Small Reconstruction Plate · Synthes (Usa) · 1992 · recalled−50
  1. Root · 8 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
  2. 7 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
  3. 6 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
  4. 5 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
  5. 4 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
  6. 3 generations backK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
  7. 2 generations backK150126 Life Spine Cannulated ScrewsLife Spine, Inc. · 2015
  8. 1 generation backK153065 The Hammertoe Correction SystemLife Spine, Inc. · 2016
  9. This deviceK162685 2-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K915818Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa)19922
−7K990094Kmi Wrist Fusion SystemKinetikos Medical, Inc.1999—
−6K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc.1999—
−5K021321Wrist Fusion PlateAcu Med, Inc.2002—
−4K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.2005—
−3K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma2009—
−2K150126Life Spine Cannulated ScrewsLife Spine, Inc.2015—
−1K153065The Hammertoe Correction SystemLife Spine, Inc.2016—
0 (this device)K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198910
199120
199220
199310
199420
199520
199650
199710
199810
199920
200030
200150
200250
200320
200510
200610
200720
200810
201010
201120
201240
201320
201430
201510
FIG. 1 — Lineage of K162685, 1992–2017Source: 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? (7)

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
*K130859Hammertoe Correction System
Summary page 4
…r Threaded Metallic Bone Fixation Fastener Classification: HWC, CFR 888.3040, Class II Primary Predicate: Arthrosurface Hammertoe Correction System (K130859) Secondary Predicate: Hammertoe Correction System (K153065) Wright Medical PhaLinx (K142585)…
Arthrosurface, Inc.2013—
*K153065The Hammertoe Correction System
Summary page 4
…HWC, CFR 888.3040, Class II Primary Predicate: Arthrosurface Hammertoe Correction System (K130859) Secondary Predicate: Hammertoe Correction System (K153065) Wright Medical PhaLinx (K142585) Arthrex BioPin (K050259)…
Life Spine, Inc.2016—
*K142585PhaLinx Hammertoe System
Summary page 4
…Arthrosurface Hammertoe Correction System (K130859) Secondary Predicate: Hammertoe Correction System (K153065) Wright Medical PhaLinx (K142585) Arthrex BioPin (K050259) Gramedica Opti-Toe (K142478)…
Wrightmedicaltechnologyinc2014—
*K050259Arthrex Bio-Pin
Summary page 4
…Secondary Predicate: Hammertoe Correction System (K153065) Wright Medical PhaLinx (K142585) Arthrex BioPin (K050259) Gramedica Opti-Toe (K142478) Pioneer Surgical Technology Stayfuse (K990804…
Arthrex, Inc.2005—
*K142478opti-Toe
Summary page 4
…(K153065) Wright Medical PhaLinx (K142585) Arthrex BioPin (K050259) Gramedica Opti-Toe (K142478) Pioneer Surgical Technology Stayfuse (K990804, K022726) Device Description: The 2-Piece Hammertoe C…
Graham Medical Technologies, LLC (D.B.A.Gramedica)2015—
*K990804Stayfuse
Summary page 4
…Arthrex BioPin (K050259) Gramedica Opti-Toe (K142478) Pioneer Surgical Technology Stayfuse (K990804, K022726) Device Description: The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that…
Pioneer Surgical Technology19992
*K022726Stayfuse GT-IP
Summary page 4
…Arthrex BioPin (K050259) Gramedica Opti-Toe (K142478) Pioneer Surgical Technology Stayfuse (K990804, K022726) Device Description: The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inser…
Pioneer Surgical Technology2002—

Also cleared against K130859: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 6 companies; a new generation was cleared every 3.0 years on median.
  • 11 of the 62 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K130859.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Indications for use as stated in the FDA summary.

Also cleared against K130859

3 other devices cite the same predicate.

  • K183228HammerToe Compression SystemParagon 28, Inc. · 2019
  • K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017
  • K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015

More from Life Spine, Inc.

85 FDA decisions under this applicant name. See the company

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  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026
  • K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026

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/K162685 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162685: 2-Piece Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162685

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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