510(k) · Cleared

Cleared

PRECICE System

K172628510(k) TraditionalCleared Sep 25, 201724-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 Sep 25, 2017 as substantially equivalent to K172061 (Nuvasive Specialized Orthopedics, Inc., 2017) after a 24-day review. Its family tree reaches back 1 generation to 2017. 16 later devices descend from it.

Decided: Sep 25, 2017
Review: 24 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K172061 (2017). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK172061 PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc. · 2017
This deviceK172628 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
Descendant · cites it directly · 13 of its ownK173129 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
Descendant · 2 generations on · 12 of its ownK180503 PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · Recalled
Descendant · 2 generations on · 6 of its ownK182170 PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
Descendant · 3 generations on · 4 of its ownK193016 PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
Descendant · cites it directly · 3 of its ownK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2017high 5 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 16 · See all

K173129PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017 · cites it directly13descendants
K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · 2 generations on12descendants
K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on6descendants
K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on4descendants
K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K172061	PRECICE UNYTE System	Nuvasive Specialized Orthopedics, Inc.	2017	—
0 (this device)	K172628	PRECICE System	Nuvasive Specialized Orthopedics, Inc.	2017	—
+1	K173129	PRECICE System	Nuvasive Specialized Orthopedics, Inc.	2017	—
+2	K180503	PRECICE STRYDE System	Nuvasive Specialized Orthopedics, Inc.	2018	1
+2	K182170	PRECICE® BONE TRANSPORT™ System	Nuvasive Specialized Orthopedics, Inc.	2019	1
+3	K193016	PRECICE Bone Transport System	Nuvasive Specialized Orthopedics, Inc.	2020	1
+1	K220234	Precice Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	1	0
2019	2	0
2020	5	0
2023	3	0
2024	1	0
2026	3	0

FIG. 1 — Lineage of K172628, 2017–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K172061	PRECICE UNYTE System Summary page 5 …Trade Name: PRECICE UNYTE System Common Name: Intramedullary Fixation Rod 510(k) Clearance Number: K172061 In addition, the PRECICE System designates the following 510(k) cleared reference devices: Trade Name: PRECIC…	Nuvasive Specialized Orthopedics, Inc.	2017	—
†	K170346	PRECICE Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2017	—
†	K170169	PRECICE Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2017	—
†	K160267	PRECICE Trauma Nail System	Ellipse Technologies, Incorporated	2016	—
†	K162927	PRECICE UNYTE CoCr System	Nuvasive Specialized Orthopedics, Inc.	2017	—

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K173129	PRECICE System	Nuvasive Specialized Orthopedics, Inc.	2017	13
K220234	Precice Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2023	3
K193617	Precice® Screws	Nuvasive Specialized Orthopedics, Inc.	2020	0

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?

Its one ancestor has no recall.
Of its descendants, K173129 (Nuvasive Specialized Orthopedics, Inc., 2017) has gone furthest, with 13 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

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

The PRECICE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of long bones.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172628 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172628: PRECICE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172628

Report an extraction error

Are you the manufacturer?

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