510(k) Report

510(k) · Cleared

Cleared

Shotel Ankle Arthrodesis Nail System

K163627510(k) TraditionalCleared Sep 14, 2017266-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

Biopro, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 14, 2017 as substantially equivalent to K100925 (Ascension Orthopedics, Inc., 2010) and 2 other predicates after a 266-day review. Its family tree reaches back 2 generations to 2005.

Decided
Sep 14, 2017
Review
266 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K043583 (2005). 6 ancestors in all, the oldest K000080 (2000). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2000: 1 other ancestor2009: 1 other ancestor2005: 1 other ancestorK043583 · Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 · Wrightmedicaltechnologyinc · 2005K053394 · Nexa Bone Screw System · Nexa Orthopedics, Inc. · 20052000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K053394 · Nexa Bone Screw System · Nexa Orthopedics, Inc. · 2005K043583 · Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 · Wrightmedicaltechnologyinc · 20050
  1. Root · 2 generations backK043583 Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003Wrightmedicaltechnologyinc · 2005
  2. 1 generation backK053394 Nexa Bone Screw SystemNexa Orthopedics, Inc. · 2005
  3. This deviceK163627 Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K043583Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003Wrightmedicaltechnologyinc2005—
−1K053394Nexa Bone Screw SystemNexa Orthopedics, Inc.2005—
0 (this device)K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
200910
201010
FIG. 1 — Lineage of K163627, 2005–2017Source: 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 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? (3)

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
*K100925Ascension Ankle Fusion Nail System
Summary page 4
…lary And Accessories CLASSIFICATION: Class II 21 CFR § 888.3020 Intramedullary Fixation Rod PREDICATE DEVICES: Ascension® Ankle Fusion Nail System - K100925 Howmedica Osteonics Asnis III Cannulated Screw System (K000080) Nexa Orthoped…
Ascension Orthopedics, Inc.2010—
*K000080Asnis Iii Cannulated Screw System
Summary page 4
…ary Fixation Rod PREDICATE DEVICES: Ascension® Ankle Fusion Nail System - K100925 Howmedica Osteonics Asnis III Cannulated Screw System (K000080) Nexa Orthopedics Nexa Bone Screw System (K053394) PRODUCT DESCRIPTION The Shotel Ankle Arthrodesis…
Howmedica Osteonics Corp.20001
*K053394Nexa Bone Screw System
Summary page 4
…em - K100925 Howmedica Osteonics Asnis III Cannulated Screw System (K000080) Nexa Orthopedics Nexa Bone Screw System (K053394) PRODUCT DESCRIPTION The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone sc…
Nexa Orthopedics, Inc.2005—

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 11.8 years on median.
  • 3 of the 6 ancestors have a recall of any class.

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. 2017, 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 Shotel Ankle Arthrodesis Nail System is intended for the following:

• Charcot Foot

• Avascular necrosis of the talus

• Failed total ankle arthroplasty

• Trauma (malunited tibial pilon fracture)

• Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease

• Revision ankle arthrodesis

• Neuroarthropathy

• Rheumatoid arthritis

• Osteoarthritis

• Pseudoarthrosis

• Post-Traumatic arthrosis

• Previously infected arthrosis

• Severe end stage degenerative arthritis

• Severe defects after tumor resection

• Pantalar arthrodesis

Indications for use as stated in the FDA summary.

More from Biopro, Inc.

41 FDA decisions under this applicant name. See the company

  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012
  • K100761Biopro Polar HeadBiopro, Inc. · 20101 recall

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/K163627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163627: Shotel Ankle Arthrodesis 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/K163627

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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