510(k) · Cleared

Cleared

Aap Loqteq Proximal Medial Tibia Plate 3.5

K132554510(k) TraditionalCleared Oct 3, 201350-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 Oct 3, 2013 as substantially equivalent to K050646 (Synthes (Usa), 2005) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Oct 3, 2013
Review: 50 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K023802 (2003). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK023802 Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSynthes (Usa) · 2003
This deviceK132554 Aap Loqteq Proximal Medial Tibia Plate 3.5Aap Implantate AG · 2013
Descendant · cites it directly · 0 of its ownK220199 AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022

Most influential descendants

Showing 1 of 1 · See all

K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023802	Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System	Synthes (Usa)	2003	—
0 (this device)	K132554	Aap Loqteq Proximal Medial Tibia Plate 3.5	Aap Implantate AG	2013	—
+1	K220199	AFFINITY Proximal Tibia System	Techfit Digital Surgery, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K132554, 2003–2022Source: 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? (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
*	K050646	Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates Summary page 1 …7/ HRS Panel Code: Predicate device: Synthes (USA) 3.5 mm LOP® Medial Proximal Tibia Plates under the premarket notification K050646 (Apr 26, 2005) and Synthes (USA) 4.5 mm Titanium LOP Proximal Tibia…	Synthes (Usa)	2005	—
*	K023802	Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System Summary page 1 …and Synthes (USA) 4.5 mm Titanium LOP Proximal Tibia Plat- ing System under the premarket notification K023802 (Jan 28, 2003). Device Description: The asp LOOTEQO Proximal Tibia Plate 3.5 System co…	Synthes (Usa)	2003	—

Also cleared against K050646: 7 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K220199	AFFINITY Proximal Tibia System	Techfit Digital Surgery, Inc.	2022	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?

None of the 2 ancestors has a recall.
Of its descendants, K220199 (Techfit Digital Surgery, Inc., 2022) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K050646.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 aap LOQTEQ Proximal Medial Tibia Plate 3.5 is indicated for * Metaphyseal fractures of the medial tibial plateau * Split fractures of the medial tibial plateau * Medial split fractures with depression * Split or depression fracture of the medial tibial plateau In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia. The aap LOQTEQ Proximal…

Read the full statement (113 words)

The aap LOQTEQ Proximal Medial Tibia Plate 3.5 is indicated for

* Metaphyseal fractures of the medial tibial plateau

* Split fractures of the medial tibial plateau

* Medial split fractures with depression

* Split or depression fracture of the medial tibial plateau

In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia.

The aap LOQTEQ Proximal Lateral Tibia Plate 3.5 is indicated for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132554: Aap Loqteq Proximal Medial Tibia Plate 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132554

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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