510(k) · Cleared

Cleared

Aap Bone Plates and Screw Implants

K072411510(k) TraditionalCleared Mar 20, 2008206-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 Mar 20, 2008 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) and 3 other predicates after a 206-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.

Decided: Mar 20, 2008
Review: 206 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K974908 (1998). 4 ancestors in all. 9 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK974908 Synthes Sterile 2.7 MM Reconstruction PlatesSynthes (Usa) · 1998
This deviceK072411 Aap Bone Plates and Screw ImplantsAap Implantate AG · 2008
Descendant · cites it directly · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
Descendant · cites it directly · 1 of its ownK223772 PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH · 2023
Descendant · 2 generations on · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
Descendant · 2 generations on · 0 of its ownK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
Descendant · 2 generations on · 0 of its ownK210658 Volition Plating SystemOrtho Solutions UK, Ltd. · 2021

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012high 1 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all

K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly2descendants
K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH · 2023 · cites it directly1descendant
K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · 2 generations on1descendant
K260054I.T.S. PRS Phoenix III.T.S. GmbH · 2026 · 2 generations on0descendants
K210658Volition Plating SystemOrtho Solutions UK, Ltd. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974908	Synthes Sterile 2.7 MM Reconstruction Plates	Synthes (Usa)	1998	—
0 (this device)	K072411	Aap Bone Plates and Screw Implants	Aap Implantate AG	2008	—
+1	K120360	Ortho Solutions Trauma Plates for Osteosysnthesis	Ortho Solutions Limited	2012	—
+1	K223772	PRO Plating System, Stryker Trauma Pelvic Set (Matta)	Stryker GmbH	2023	—
+2	K202764	Ortho Solutions Plating System	Ortho Solutions UK, Ltd.	2020	—
+2	K260054	I.T.S. PRS Phoenix II	I.T.S. GmbH	2026	—
+2	K210658	Volition Plating System	Ortho Solutions UK, Ltd.	2021	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2019	1	0
2020	1	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K072411, 1998–2026Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120… Summary page 4 …ices for Substantial Equivalence: The cap bone plates and screws are similar in size, material and intended use to * Syntec-Taichung Bone Plate and Screw Implants (K983495) * Synthes Sterile 2.7mm Reconstruction Plates (K974908) * Synthes Bone Plates and Bone Screws for standard Osteosynt…	Syntec Scientific Corp.	1998	—
*	K974908	Synthes Sterile 2.7 MM Reconstruction Plates Summary page 4 …ws are similar in size, material and intended use to * Syntec-Taichung Bone Plate and Screw Implants (K983495) * Synthes Sterile 2.7mm Reconstruction Plates (K974908) * Synthes Bone Plates and Bone Screws for standard Osteosynthesis (Prea- mendment * Stryker Trauma Plating S…	Synthes (Usa)	1998	—
*	K000636	Stryker Trauma Plating System	Howmedica Osteonics Corp.	2000	—
*	K012162	Stryker Plating System Basic Fragment Set Summary page 4 …es and Bone Screws for standard Osteosynthesis (Prea- mendment * Stryker Trauma Plating System [KO00636) * Stryker Plating System Basic Fragment Set (K012162) Comparision of the technological Characteristics of the device to the predicate legally marketed devices: There are no signifi…	Howmedica Osteonics Corp.	2001	—
*	—	Synthes Bone Plates and Bone Screws for standard Osteosynthesis (Preamendment) Named without a submission number			—

Also cleared against K983495: 10 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K120360	Ortho Solutions Trauma Plates for Osteosysnthesis	Ortho Solutions Limited	2012	2
K223772	PRO Plating System, Stryker Trauma Pelvic Set (Matta)	Stryker GmbH	2023	1
K182818	LOQTEQ VA Calcaneus Plate 3.5	Aap Implantate AG	2019	0
K161703	LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer	Aap Implantate AG	2016	0
K150974	aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium	Aap Implantate AG	2015	0
K141949	Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…	Aap Implantate AG	2014	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 4 ancestors has a recall.
Of its descendants, K120360 (Ortho Solutions Limited, 2012) has gone furthest, with 2 descendants of its own.
10 other devices also cite its predicate K983495.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All oop bone plates and screws are for single use only and are not intended for any spinal fixation procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072411: Aap Bone Plates and Screw Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072411

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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