510(k) Report

510(k) · Cleared

Cleared

Force Medical IM Nail System

K102577510(k) TraditionalCleared May 3, 2012603-day reviewClass II21 CFR 888.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Force Medical, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 3, 2012 as substantially equivalent to K051590 (Howmedica Osteonics Corp., 2005) and 4 other predicates after a 603-day review. Its family tree reaches back 3 generations to 1998.

Decided
May 3, 2012
Review
603 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K982953 (1998). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2009: 2 other ancestors2005: 1 other ancestor2002: 1 other ancestor2007: 2 other ancestors1999: 1 other ancestorK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalledK021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK081243 · Biomet Phoenix Ankle Nail System · Biomet Trauma · 20081995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 4 other ancestors K081243 · Biomet Phoenix Ankle Nail System · Biomet Trauma · 2008K021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled0
  1. Root · 3 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
  2. 2 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
  3. 1 generation backK081243 Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
  4. This deviceK102577 Force Medical IM Nail SystemForce Medical, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K982953Titanium Intramedullary Nails-Various StylesBiomet, Inc.19984
−2K021786Titanium Ankle Arthrodesis NailBiomet, Inc.20021
−1K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma2008—
0 (this device)K102577Force Medical IM Nail SystemForce Medical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200510
200720
200920
201110
FIG. 1 — Lineage of K102577, 1998–2012Source: 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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
*K051590T2 Ankle Arthrodesis Nail
Summary page 1
….3030) DEVICE PRODUCT CODE: HSB SUBSEQUENT PRODUCT CODE: JDS SUBSTANTIALLY EQUIVALENT DEVICES: Stryker - T2 Ankle Arthrodesis Nail (1(051590, K(020384) Biomet - Phoenix Nail Systems (K(091976, K(081243) Wright Medical - Valo…
Howmedica Osteonics Corp.20058
*K020384T2 Arthrodesis Nail System
Summary page 1
…VICE PRODUCT CODE: HSB SUBSEQUENT PRODUCT CODE: JDS SUBSTANTIALLY EQUIVALENT DEVICES: Stryker - T2 Ankle Arthrodesis Nail (1(051590, K(020384) Biomet - Phoenix Nail Systems (K(091976, K(081243) Wright Medical - Valor Ankle Fu…
Howmedica Osteonics Corp.20021
*K091976Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail
Summary page 1
…: JDS SUBSTANTIALLY EQUIVALENT DEVICES: Stryker - T2 Ankle Arthrodesis Nail (1(051590, K(020384) Biomet - Phoenix Nail Systems (K(091976, K(081243) Wright Medical - Valor Ankle Fusion Nail (K110552) DEVICE DESCRIPTION: The Force Medical IM…
Biomet Trauma20092
*K081243Biomet Phoenix Ankle Nail System
Summary page 1
…JDS SUBSTANTIALLY EQUIVALENT DEVICES: Stryker - T2 Ankle Arthrodesis Nail (1(051590, K(020384) Biomet - Phoenix Nail Systems (K(091976, K(081243) Wright Medical - Valor Ankle Fusion Nail (K110552) DEVICE DESCRIPTION: The Force Medical IM Nail Syste…
Biomet Trauma2008—
*K110552Valor (R) Ankle Fusion Nail System Screw
Cleared while this submission was under review
Summary page 1
…esis Nail (1(051590, K(020384) Biomet - Phoenix Nail Systems (K(091976, K(081243) Wright Medical - Valor Ankle Fusion Nail (K110552) DEVICE DESCRIPTION: The Force Medical IM Nail System is an angled (left & right) and straight (left &…
Wrightmedicaltechnologyinc2011—

Also cleared against K051590: 9 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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 7 of the 11 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K051590.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

Indications for use include:

> Posttraumatic and primary Arthrosis

> Neuromuscular deformity

> Revision of Failed Ankle Arthrodesis

> Failed Total Ankle Replacement

> Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)

> Neuroarthropathy (Charcot)

> Rheumatoid Arthritis with severe deformity

> Osteoarthritis

> Pseudarthrosis

Indications for use as stated in the FDA summary.

Also cleared against K051590

9 other devices cite the same predicate.

  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2…Stryker GmbH · 2020
  • K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018
  • K163589SIGN IM NailSign Fracture Care International · 2017
  • K130051611 Ankle Fusion NailTornier S.A.S. · 2013
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K102577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102577: Force Medical IM Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102577

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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