510(k) Report

510(k) · Cleared

Cleared

PRECICE UNYTE System

K172061510(k) TraditionalCleared Aug 24, 201748-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

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

Cleared on Aug 24, 2017 after a 48-day review. The FDA summary names no predicate by number. 17 later devices descend from it.

Decided
Aug 24, 2017
Review
48 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2020: 5 descendants cleared2023: 3 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2026: 3 descendants cleared2024: 1 descendant cleared201620182020202220242026
  1. This deviceK172061 PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  2. Descendant · cites it directly · 16 of its ownK172628 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  3. Descendant · 2 generations on · 13 of its ownK173129 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
  4. Descendant · 3 generations on · 12 of its ownK180503 PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · Recalled
  5. Descendant · 3 generations on · 6 of its ownK182170 PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK193016 PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2017: 22018: 12019: 22020: 52023: 32024: 12026: 3
2017high 5 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 17 · See all
  • K172628PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017 · cites it directly16descendants
  • K173129PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017 · 2 generations on13descendants
  • K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · 3 generations on12descendants
  • K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 3 generations on6descendants
  • K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K172061PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc.2017—
+1K172628PRECICE SystemNuvasive Specialized Orthopedics, Inc.2017—
+2K173129PRECICE SystemNuvasive Specialized Orthopedics, Inc.2017—
+3K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc.20181
+3K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc.20191
+4K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc.20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201810
201920
202050
202330
202410
202630
FIG. 1 — Lineage of K172061, 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K172628PRECICE SystemNuvasive Specialized Orthopedics, Inc.201716

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?

  • Of its descendants, K172628 (Nuvasive Specialized Orthopedics, Inc., 2017) has gone furthest, with 16 descendants of its own.

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—

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/K172061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172061: PRECICE UNYTE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172061

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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