510(k) Report

510(k) · Cleared

Cleared

SP2 Femoral Locking Nail, SP2 Tibial Locking Nail

K123745510(k) TraditionalCleared Mar 25, 2013109-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

Biomecanica Industria E Comerico DE Productos Orto · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 25, 2013 as substantially equivalent to K112059 (Stryker, 2011) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 2001.

Decided
Mar 25, 2013
Review
109 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K010801 (2001). 6 ancestors in all, the oldest K003018 (2000). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor2008: 1 other ancestor2002: 2 other ancestorsK010801 · T2 Femoral Nail · Howmedica Osteonics Corp. · 2001 · recalledK112059 · T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp · Stryker · 20112000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors K112059 · T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp · Stryker · 2011K010801 · T2 Femoral Nail · Howmedica Osteonics Corp. · 2001 · recalled0
  1. Root · 2 generations backK010801 T2 Femoral NailHowmedica Osteonics Corp. · 2001 · Recalled
  2. 1 generation backK112059 T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011
  3. This deviceK123745 SP2 Femoral Locking Nail, SP2 Tibial Locking NailBiomecanica Industria E Comerico DE Productos Orto · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010801T2 Femoral NailHowmedica Osteonics Corp.20012
−1K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker2011—
0 (this device)K123745SP2 Femoral Locking Nail, SP2 Tibial Locking NailBiomecanica Industria E Comerico DE Productos Orto2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200220
200810
FIG. 1 — Lineage of K123745, 2001–2013Source: 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? (2)

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
*K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp
Summary page 1
…umber & Product Codes HSB-21 CFR §888,3020 Proposed Regulatory Class Class II Predicate Device Identification T2 Femoral Nail K112059 Titan Tibial Nail K003018 Description of Proposed Device The Biomecanica SP2 Femoral Loc…
Stryker2011—
*K003018Titan Tibial Nail
Summary page 1
…Regulatory Class Class II Predicate Device Identification T2 Femoral Nail K112059 Titan Tibial Nail K003018 Description of Proposed Device The Biomecanica SP2 Femoral Locking Nail is a cylindrical, cannulated titanium alloy tube, slight…
Howmedica Osteonics Corp.200022

Also cleared against K112059: 4 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 12 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K112059.

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. 2013, 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 SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following: * Open and closed femoral fractures * Pseudloarthrosis and correction osteotomy * Pathologic fractures, including those with intra-articular extension * Ipsilateral femur fractures * Fractures proximal to a total knee arthroplasty * Fractures distal to the hip joint * Nonunions and malunions The SP2 Tibial Locking Nail…

Read the full statement (137 words)

The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following:

* Open and closed femoral fractures

* Pseudloarthrosis and correction osteotomy

* Pathologic fractures, including those with intra-articular extension

* Ipsilateral femur fractures

* Fractures proximal to a total knee arthroplasty

* Fractures distal to the hip joint

* Nonunions and malunions

The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following:

* Open or closed shaft fractures with a very proximal and very dlistal extent in which locking screw fixation can be obtained

* Pseudlarthrosis

* Pathologic and impending pathologic fractures

* Multi-fragment fractures

* Segmental fractures

* Proximal or distal non-unions

* Corrective osteotomies

* Tumor resections

* Comminuted fractures with or without bone loss

Indications for use as stated in the FDA summary.

Also cleared against K112059

4 other devices cite the same predicate.

  • K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
  • K152295Talon DistalFix Antegrade/Retrograde Femoral NailOrthopedic Designs North America, Inc. · 2015
  • K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company · 2015
  • K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014

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/K123745 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123745: SP2 Femoral Locking Nail, SP2 Tibial Locking Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123745

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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