510(k) · Cleared

Cleared

Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set

K020221510(k) TraditionalCleared Apr 2, 200270-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

Biomet Orthopedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Apr 2, 2002 after a 70-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.

Decided: Apr 2, 2002
Review: 70 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

23 later devices descend from it, 5 citing it directly.

This deviceK020221 Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql…Biomet Orthopedics, Inc. · 2002
Descendant · cites it directly · 15 of its ownK090666 PediplatesOrthoPediatrics Corp. · 2009
Descendant · 2 generations on · 13 of its ownK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
Descendant · 3 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
Descendant · cites it directly · 3 of its ownK093761 Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp) · 2010
Descendant · 4 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2003high 3 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 23 · See all

K090666PediplatesOrthoPediatrics Corp. · 2009 · cites it directly15descendants
K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010 · 2 generations on13descendants
K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 3 generations on7descendants
K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp) · 2010 · cites it directly3descendants
K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K020221	Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment…	Biomet Orthopedics, Inc.	2002	—
+1	K090666	Pediplates	OrthoPediatrics Corp.	2009	—
+2	K100240	Orthopediatrics Pediloc Tibia Plate System	OrthoPediatrics Corp.	2010	—
+3	K111086	Orthopediatrics Fracture and Osteotomy Bone Plate System	OrthoPediatrics Corp.	2011	1
+1	K093761	Optilock VL (Variable Angle Locking) Distal Radius Plating System	Biomet Trauma (Aka Ebi, Lp)	2010	—
+4	K192181	PRECICE Plating System	Nuvasive Specialized Orthopedics, Inc.	2019	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0
2009	1	0
2010	3	0
2011	3	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2019	2	0
2020	3	0
2022	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K020221, 2002–2026Source: 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
*	—	Various stainless steel bone plates and screws sold by Biomet Inc. (OEC) prior to May… Named without a submission number			—
†	K864924	Kirschner (R) Small Fragment Fixation System	Kirschner Medical Corp.	1987	—

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K090666	Pediplates	OrthoPediatrics Corp.	2009	15
K093761	Optilock VL (Variable Angle Locking) Distal Radius Plating System	Biomet Trauma (Aka Ebi, Lp)	2010	3
K093983	Smple Plate and Screws	Biomet Trauma (Aka Ebi, Lp)	2010	0
K071325	Biomet Variable Locking Plate System	Biomet Trauma	2007	0
K031334	Texas T - Plate	Biomet, Inc.	2003	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?

Of its descendants, K090666 (OrthoPediatrics Corp., 2009) has gone furthest, with 15 descendants of its own.

How does its category compare?

All HRS devices

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

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?

IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteatomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020221

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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