510(k) · Cleared

Cleared

Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws

K120802510(k) SpecialCleared Apr 2, 201217-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 Apr 2, 2012 as substantially equivalent to K102429 (Wrightmedicaltechnologyinc, 2010) and 1 other predicate after a 17-day review. Its family tree reaches back 3 generations to 2008. 11 later devices descend from it.

Decided: Apr 2, 2012
Review: 17 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K082320 (2008). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
2 generations backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
1 generation backK112772 Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
This deviceK120802 Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2012
Descendant · cites it directly · 10 of its ownK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
Descendant · 2 generations on · 2 of its ownK181820 Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
Descendant · 2 generations on · 1 of its ownK202959 PolyLock Plating SystemFusion Orthopedics, LLC · 2020
Descendant · 2 generations on · 1 of its ownK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015high 2 (2018) · low 0 (2017)2026

Most influential descendants

Showing 5 of 11 · See all

K151235Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015 · cites it directly10descendants
K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018 · 2 generations on2descendants
K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024 · 2 generations on1descendant
K202959PolyLock Plating SystemFusion Orthopedics, LLC · 2020 · 2 generations on1descendant
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K082320	Darco Small Screw	Wrightmedicaltechnologyinc	2008	—
−2	K102429	Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw	Wrightmedicaltechnologyinc	2010	1
−1	K112772	Ortholoc (TM) Bone Screws	Wrightmedicaltechnologyinc	2011	—
0 (this device)	K120802	Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws	Wrightmedicaltechnologyinc	2012	—
+1	K151235	Medline Foot Plates and Screws	Medline Industries, Inc.	2015	—
+2	K181820	Medline Unite Mini Plates and Screws	Medline Industries, Inc.	2018	—
+2	K234031	Medline UNITE Ancillary Foot Recon Plating System	Medline Industires, LP	2024	—
+2	K202959	PolyLock Plating System	Fusion Orthopedics, LLC	2020	—
+2	K162829	Medline UNITE® Ankle Fracture Plating System	Medline Industries, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2018	2	0
2020	1	0
2022	2	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K120802, 2008–2025Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K102429	Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw Summary page 1 …HRS: Plate, Fixation, Bone 87 Orthopedics A.3. Predicate Devices: K102429-ORTHOLOCTm 31)i Ankle Plating System and ORTFIOLOCTM Bone…	Wrightmedicaltechnologyinc	2010	1
*	K112772	Ortholoc (TM) Bone Screws	Wrightmedicaltechnologyinc	2011	—

Also cleared against K102429: 8 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K151235	Medline Foot Plates and Screws	Medline Industries, Inc.	2015	10

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 4 years and passes through 1 company; a new generation was cleared every 10 months on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K151235 (Medline Industries, Inc., 2015) has gone furthest, with 10 descendants of its own.
8 other devices also cite its predicate K102429.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

Wright's ORTHOLOC 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: * Lateral Malleolar Fractures * Syndesmosis injuries * Medial Malleolar Fractures * Bi-Malleolar Fractures * Tri-Malleolar Fractures * Posterior Malleolar Fractures * Distal Anterior Tibia Fractures * Vertical Shear Fractures of the Medial Malleolous * Pilon Fractures * Distal Tibia Shaft Fractures * Distal…

Read the full statement (164 words)

Wright's ORTHOLOC 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

* Lateral Malleolar Fractures

* Syndesmosis injuries

* Medial Malleolar Fractures

* Bi-Malleolar Fractures

* Tri-Malleolar Fractures

* Posterior Malleolar Fractures

* Distal Anterior Tibia Fractures

* Vertical Shear Fractures of the Medial Malleolous

* Pilon Fractures

* Distal Tibia Shaft Fractures

* Distal Fibula Shaft Fractures

* Distal Tibia Periarticular Fractures

* Medial Malledlar Avulsion Fractures

* Lateral Malleolar Avusion Fractures

The ORTHOLOC 3Di locking screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.

ORTHOLOC Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120802: Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120802

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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