510(k) Report

510(k) · Cleared

Cleared

Odi Talon Long Proximal Femoral Nail System

K033286510(k) TraditionalCleared Jan 12, 200490-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

Orthopedic Designs, Inc. (Odi) · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jan 12, 2004 as substantially equivalent to K895241 (Richards Medical Co., Inc., 1990) and 8 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.

Decided
Jan 12, 2004
Review
90 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
9

Its longest line of descent runs back 3 generations to K850886 (1985). 21 ancestors in all, the oldest K781762 (1978). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1992: 3 other ancestors1991: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1982: 1 other ancestor1979: 1 other ancestor1978: 1 other ancestor2011: 1 descendant cleared2023: 1 descendant clearedK850886 · Compression Hip Screw System · Pfizer, Inc. · 1985 · recalledK955306 · Omega+ Compression Screw System · Howmedica Corp. · 1996 · recalledK984331 · Odi Ultimate Compression Hip Screw · Orthopedic Designs, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 8 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K984331 · Odi Ultimate Compression Hip Screw · Orthopedic Designs, Inc. · 1999K955306 · Omega+ Compression Screw System · Howmedica Corp. · 1996 · recalledK850886 · Compression Hip Screw System · Pfizer, Inc. · 1985 · recalled0
  1. Root · 3 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
  2. 2 generations backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
  3. 1 generation backK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
  4. This deviceK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
  5. Descendant · cites it directly · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
  6. Descendant · 2 generations on · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · cites it directly1descendant
  • K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K850886Compression Hip Screw SystemPfizer, Inc.19851
−2K955306Omega+ Compression Screw SystemHowmedica Corp.19961
−1K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.1999—
0 (this device)K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)2004—
+1K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.2011—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198210
198610
198710
198910
199020
199110
199230
199420
199520
199710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202310
FIG. 1 — Lineage of K033286, 1985–2023Source: 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 510(k) statement (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? (9)

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
*K895241Intramedullary Hip Screw
Summary page 3
…ilization. Within the proposed class, the following devices are used as predicate devices for comparison: Smith & Nephew Richards - Intramedullary Hip Screw (K895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System…
Richards Medical Co., Inc.1990—
*K912162Intramedullary Hip Screw, Modification
Summary page 3
…. Within the proposed class, the following devices are used as predicate devices for comparison: Smith & Nephew Richards - Intramedullary Hip Screw (K895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System…
Smith & Nephew Richards, Inc.1991—
*K921786Intramedullary Hip Screw
Summary page 3
…e devices for comparison: Smith & Nephew Richards - Intramedullary Hip Screw (K895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System (K893639, K972813,…
Smith & Nephew Richards, Inc.1992—
*K954712Intramedullary Hip Screw (Modification)
Summary page 3
…for comparison: Smith & Nephew Richards - Intramedullary Hip Screw (K895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System (K893639, K972813,…
Smith & Nephew Richards, Inc.1995—
*K893639Gamma Locking Nail
Summary page 3
…(K895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System (K893639, K972813, K944883) Orthopedic Designs - TALON T M…
Howmedica Corp.1989—
*K972813Gamma Locking Nail System
Summary page 3
…895241, K912162, K921786, K954712) Howmedica - Gamma Locking Nail System (K893639, K972813, K944883) Orthopedic Designs - TALON T M…
Howmedica Corp.1997—
*K944883Gamma Locking Nail - Long Length
Summary page 3
…K921786, K954712) Howmedica - Gamma Locking Nail System (K893639, K972813, K944883) Orthopedic Designs - TALON T M Intramedullary Hip Nail (K014189) Orthopedic Designs…
Howmedica Corp.1994—
*K014189Odi Talon Intramedullary Hip Nail
Summary page 3
…K944883) Orthopedic Designs - TALON T M Intramedullary Hip Nail (K014189) Orthopedic Designs - TALON T M Compression Hip Screw (K984331) Each of these produ…
Orthopedic Designs, Inc.2002—
*K984331Odi Ultimate Compression Hip Screw
Summary page 2
…LON T M Lag Screw used inthe nail system is completely compatible with ODi's TALON TM Compression Hip Screw system and has been previously approved by the FDA in K984331. The TALON T M lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These…
Orthopedic Designs, Inc.1999—

Also cleared against K895241: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111

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 19 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
  • 5 of the 21 ancestors have a recall of any class.
  • Of its descendants, K111352 (Orthopedic Designs North America, Inc., 2011) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K895241.

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.

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 ODi TALON TM Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Indications for use as stated in the FDA 510(k) statement.

Also cleared against K895241

2 other devices cite the same predicate.

  • K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 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/K033286 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033286: Odi Talon Long Proximal Femoral 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/K033286

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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