510(k) · Cleared

Cleared

Evolve Eps Ortholoc

K102352510(k) SpecialCleared Dec 2, 2010105-day reviewClass II21 CFR 888.3030

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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on Dec 2, 2010 as substantially equivalent to K100146 (Wrightmedicaltechnologyinc, 2010) after a 105-day review. Its family tree reaches back 1 generation to 2010. 102 later devices descend from it.

Decided: Dec 2, 2010
Review: 105 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K100146 (2010). 102 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK100146 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
This deviceK102352 Evolve Eps OrtholocWrightmedicaltechnologyinc · 2010
Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
Descendant · 2 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
Descendant · 3 generations on · 24 of its ownK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
Descendant · 3 generations on · 23 of its ownK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

2011high 12 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 102 · See all

K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 2 generations on95descendants
K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
K143025Total Compression Plating SystemWrightmedicaltechnologyinc · 2014 · 3 generations on24descendants
K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015 · 3 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K100146	Evolve Eps Ortholoc	Wrightmedicaltechnologyinc	2010	—
0 (this device)	K102352	Evolve Eps Ortholoc	Wrightmedicaltechnologyinc	2010	—
+1	K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	12
+2	K121651	Ortholoc 3DI Midfoot/Flatfoot System	Wrightmedicaltechnologyinc	2012	—
+3	K140397	Paralock Plating System / Tuffnek Screw	Paragon 28	2014	—
+3	K143025	Total Compression Plating System	Wrightmedicaltechnologyinc	2014	—
+3	K151442	Total Compression Plating (TCP) System	Wrightmedicaltechnologyinc	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	2	0
2014	3	0
2015	6	0
2016	4	0
2017	9	0
2018	6	0
2019	7	0
2020	12	0
2021	9	0
2022	6	0
2023	11	0
2024	11	0
2025	7	0
2026	7	0

FIG. 1 — Lineage of K102352, 2010–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K100146	Evolve Eps Ortholoc Summary page 1 …87 Orthopedics A.3. Predicate Device: EVOLVE® BPS ORTHOLOCTM System (K100146) AA4 Device Description The EVOLVE® BPS OTFIOLOCTM System is extended to offer two longer screw lengths and four shorte…	Wrightmedicaltechnologyinc	2010	—

Also cleared against K100146: 1 other device →

What descends from it? (102)

See all 102

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

Number	Device	Applicant	Decided	Descendants
K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	97
K111432	Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone Screws	Wrightmedicaltechnologyinc	2011	2
K181587	ORTHOLOC SPS Shoulder Plating System	Tornier, Inc.	2018	1
K113339	Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2011	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, K113014 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 97 descendants of its own.
1 other device also cites its predicate K100146.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The EVOLVE® BPS ORTHOLOC™ is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102352 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102352: Evolve Eps Ortholoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102352

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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