510(k) · Cleared

Cleared

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer

K161703510(k) TraditionalCleared Nov 4, 2016137-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

Aap Implantate AG · HRS Plate, Fixation, Bone

Cleared on Nov 4, 2016 as substantially equivalent to K113652 (Aap Implantate AG, 2012) and 2 other predicates after a 137-day review. Its family tree reaches back 4 generations to 2000.

Decided: Nov 4, 2016
Review: 137 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K000684 (2000). 11 ancestors in all, the oldest K974908 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
3 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
2 generations backK082527 Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc. · 2008 · Recalled
1 generation backK113652 Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15…Aap Implantate AG · 2012
This deviceK161703 LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−3	K060710	Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws	Zimmer, Inc.	2006	5
−2	K082527	Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws	Zimmer, Inc.	2008	5
−1	K113652	Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self…	Aap Implantate AG	2012	—
0 (this device)	K161703	LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer	Aap Implantate AG	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2000	1	0
2001	2	0
2008	1	0

FIG. 1 — Lineage of K161703, 2000–2016Source: 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? (3)

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
*	K113652	Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq… Summary page 4 …Orthopedics/87/HTN (3) Predicate devices LOQTEQ® 1/3 Tubular Plate 3.5 under the premarket notification K113652 (LOQTEQ® Small Fragment Set) Cancellous Screw 4.0 under the premarket notification K072411…	Aap Implantate AG	2012	—
*	K072411	Aap Bone Plates and Screw Implants Summary page 4 …market notification K113652 (LOQTEQ® Small Fragment Set) Cancellous Screw 4.0 under the premarket notification K072411 Washer under the premarket notification K990776 (4) Device Description: The aap Plate and…	Aap Implantate AG	2008	—
*	K990776	Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM Summary page 4 …nt Set) Cancellous Screw 4.0 under the premarket notification K072411 Washer under the premarket notification K990776 (4) Device Description: The aap Plate and Screw System LOQTEQ® Distal Fibula Plates consist…	Aap Implantate AG	1999	—

Also cleared against K113652: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
4 of the 11 ancestors have a recall of any class.
4 other devices also cite its predicate K113652.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161703: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161703

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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