510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

PRECICE® BONE TRANSPORT™ System

K182170510(k) TraditionalCleared Feb 5, 2019179-day reviewClass II21 CFR 888.3020Recalls 1

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

Nuvasive Specialized Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 5, 2019 as substantially equivalent to K173129 (Nuvasive Specialized Orthopedics, Inc., 2017) and 1 other predicate after a 179-day review. Its family tree reaches back 4 generations to 2017. 6 later devices descend from it. It has been recalled once.

Decided
Feb 5, 2019
Review
179 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K172061 (2017). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2020: 3 descendants cleared2024: 1 descendant cleared2026: 2 descendants cleared×2: 2 generations cleared close together, K172061 (2017), K172628 (2017) K173129 · PRECICE System · Nuvasive Specialized Orthopedics, Inc. · 2017K180503 · PRECICE STRYDE System · Nuvasive Specialized Orthopedics, Inc. · 2018 · recalled201620182020202220242026
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants K180503 · PRECICE STRYDE System · Nuvasive Specialized Orthopedics, Inc. · 2018 · recalledK173129 · PRECICE System · Nuvasive Specialized Orthopedics, Inc. · 2017K172628 · PRECICE System · Nuvasive Specialized Orthopedics, Inc. · 2017K172061 · PRECICE UNYTE System · Nuvasive Specialized Orthopedics, Inc. · 20170
  1. Root · 4 generations backK172061 PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  2. 3 generations backK172628 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  3. 2 generations backK173129 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  4. 1 generation backK180503 PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · Recalled
  5. This deviceK182170 PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019
  6. Descendant · cites it directly · 4 of its ownK193016 PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK201567 Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
  8. Descendant · 3 generations on · 2 of its ownK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
  9. Descendant · 4 generations on · 0 of its ownK260146 Fitbone® Transport and Lengthening SystemOrthofix Srl · 2026
  10. Descendant · 4 generations on · 0 of its ownK253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System…Orthofix Srl · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 32024: 12026: 2
2020high 3 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · cites it directly4descendants
  • K201567Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on3descendants
  • K232169FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024 · 3 generations on2descendants
  • K260146Fitbone® Transport and Lengthening SystemOrthofix Srl · 2026 · 4 generations on0descendants
  • K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K172061PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc.2017—
−3K172628PRECICE SystemNuvasive Specialized Orthopedics, Inc.2017—
−2K173129PRECICE SystemNuvasive Specialized Orthopedics, Inc.2017—
−1K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc.20181
0 (this device)K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc.2019—
+1K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc.20201
+2K201567Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc.20202
+3K232169FITBONE® Transport and Lengthening SystemOrthofix Srl2024—
+4K260146Fitbone® Transport and Lengthening SystemOrthofix Srl2026—
+4K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202030
202410
202620
FIG. 1 — Lineage of K182170, 2017–2026Source: 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
*K173129PRECICE System
Summary page 4
…on: 21 CFR § 888.3020 Product Code: HSB, HWC C. Predicate Devices Predicate Device PRECICE® System (K173129) Reference Device PRECICE® Stryde System (K180503) D. Device Description The PRECICE® Bone Transpor…
Nuvasive Specialized Orthopedics, Inc.2017—
*K180503PRECICE STRYDE System
Summary page 4
…HSB, HWC C. Predicate Devices Predicate Device PRECICE® System (K173129) Reference Device PRECICE® Stryde System (K180503) D. Device Description The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws,…
Nuvasive Specialized Orthopedics, Inc.20181

Also cleared against K173129: 2 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc.20204
K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 12, 2021Class IIZ-1324-2021Under Investigation by firmDue to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 4 months on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K193016 (Nuvasive Specialized Orthopedics, Inc., 2020) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K173129.

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. 2019, 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 PRECICE® BONE TRANSPORT™ System is indicated for limb-lengthening, open and closed fracture fixation,

pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.

Indications for use as stated in the FDA summary.

Also cleared against K173129

2 other devices cite the same predicate.

  • K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019
  • K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 20181 recall

More from Nuvasive Specialized Orthopedics, Inc.

20 FDA decisions under this applicant name. See the company

  • K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023
  • K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023
  • K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
  • K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2020
  • K201567Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 20202 recalls

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/K182170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182170: PRECICE® BONE TRANSPORT™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182170

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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