510(k) · Cleared

Recalled · 2006

Profyle System

K062498510(k) TraditionalCleared Oct 25, 200661-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone

Cleared on Oct 25, 2006 as substantially equivalent to K961497 (Howmedica, Inc., 1996) and 3 other predicates after a 61-day review. Its family tree reaches back 5 generations to 1996. 81 later devices descend from it. It has been recalled once.

Decided: Oct 25, 2006
Review: 61 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 4

Its longest line of descent runs back 5 generations to K962616 (1996). 16 ancestors in all, the oldest K885250 (1989). 81 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
1 generation backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
This deviceK062498 Profyle SystemHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 61 of its ownK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
Descendant · 2 generations on · 58 of its ownK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
Descendant · 2 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
Descendant · 2 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
Descendant · 3 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2008high 15 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 81 · See all

K073527Variax Elbow SystemHowmedica Osteonics Corp. · 2008 · cites it directly61descendants
K101056Variax Elbow SystemHowmedica Osteonics Corp. · 2010 · 2 generations on58descendants
K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 2 generations on40descendants
K132502Variax 2 SystemStryker Trauma AG · 2013 · 2 generations on21descendants
K140769Variax 2 SystemStryker Trauma AG · 2014 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−4	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−3	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−2	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−1	K051567	Aptus Titanium Osteosynthesis System	Medartis, Inc.	2005	1
0 (this device)	K062498	Profyle System	Howmedica Osteonics Corp.	2006	—
+1	K073527	Variax Elbow System	Howmedica Osteonics Corp.	2008	—
+2	K101056	Variax Elbow System	Howmedica Osteonics Corp.	2010	—
+2	K113760	Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	—
+2	K132502	Variax 2 System	Stryker Trauma AG	2013	—
+3	K140769	Variax 2 System	Stryker Trauma AG	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1996	3	0
1998	2	0
2000	2	0
2002	1	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	2	0
2011	1	0
2012	1	0
2013	4	0
2014	6	0
2016	1	0
2017	7	0
2018	5	0
2019	4	0
2020	3	0
2021	3	0
2022	7	0
2023	7	0
2024	15	0
2025	6	0
2026	7	0

FIG. 1 — Lineage of K062498, 1996–2026Source: 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? (4)

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
*	K961497	Profyle Titanium Hand and Small Fragment System Summary page 1 …ng systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® Hand and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, I…	Howmedica, Inc.	1996	—
*	K980364	Howmedica and Howmedica Leibinger Bone Screw Washers Summary page 1 …n regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® Hand and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567…	Howmedica Corp.	1998	—
*	K040022	Stryker Leibinger Universal Distal Radius System Summary page 1 …principles as internal fixation components such as the Profyle® Hand and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567.)…	Stryker Leibinger	2004	—
*	K051567	Aptus Titanium Osteosynthesis System Summary page 1 …and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567.) 7 DEPARTMENT O…	Medartis, Inc.	2005	1

Also cleared against K961497: 8 other devices →

What descends from it? (81)

See all 81

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

Number	Device	Applicant	Decided	Descendants
K073527	Variax Elbow System	Howmedica Osteonics Corp.	2008	61
K180500	VariAx 2 System	Stryker GmbH	2018	12
K131566	Arix Hand System	Jeil Medical Corporation	2013	8
K132769	Acumed Hand Plating System	Acumed, LLC	2014	7
K253906	Xpert Hand	Newclip Technics	2026	0
K191972	ARIX Wrist System	Jeil Medical Corporation	2019	0
K181009	APTUS CMC-I Fusion Plate System	Medartis AG	2018	0
K132876	Arix Hand Locking System	Jeil Medical Corporation	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 26, 2006	Not classified	Z-1334-2011	Process design	A package labeled as a S T-Bone Plate, Catalog Number 57-05260, Lot Code G4M00F1576, may actually contain a M T-Compression Plate, Catalog Number 57-10250, Lot Code G4N00F1584 and vice versa.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
3 of the 16 ancestors have a recall of any class.
Of its descendants, K073527 (Howmedica Osteonics Corp., 2008) has gone furthest, with 61 descendants of its own.
8 other devices also cite its predicate K961497.

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?

The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062498: Profyle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062498

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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