510(k) · Cleared

Cleared

Synthes (Usa) Articulating Distal Radius (Adrf) System

K984498510(k) TraditionalCleared Feb 18, 199963-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

Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Feb 18, 1999 as substantially equivalent to K963618 (Synthes (Usa), 1996) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.

Decided: Feb 18, 1999
Review: 63 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K942906 (1994). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK942906 Agee-Wristjack Pre-Drill KitHand Biomechanics Lab, Inc. · 1994
This deviceK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
Descendant · cites it directly · 3 of its ownK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
Descendant · 2 generations on · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
Descendant · 3 generations on · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
Descendant · cites it directly · 0 of its ownK020311 Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002

Most influential descendants

Showing 5 of 5 · See all

K012294Wristore FixatorMillennium Medical Technologies, Inc. · 2002 · cites it directly3descendants
K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · 2 generations on1descendant
K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011 · 2 generations on0descendants
K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · 3 generations on0descendants
K020311Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942906	Agee-Wristjack Pre-Drill Kit	Hand Biomechanics Lab, Inc.	1994	—
0 (this device)	K984498	Synthes (Usa) Articulating Distal Radius (Adrf) System	Synthes (Usa)	1999	—
+1	K012294	Wristore Fixator	Millennium Medical Technologies, Inc.	2002	—
+2	K042761	Wristore Distal Radius Fracture Fixator, 4600 Series	Zimmer, Inc.	2004	—
+2	K101338	Newfix External Fixation System	Technologia Y Diseno Industrial, S.A DE C.V	2011	—
+3	K052498	Fragment Specific Fixator	David J. Slutsky MD	2005	—
+1	K020311	Clearview Wrist Fixator	Rigid FX Orthopedics, Incorporated	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	1	0
2005	1	0
2011	1	0

FIG. 1 — Lineage of K984498, 1994–2011Source: 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 KTT? 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 KTT device

#1 K242861 TrueLok Elevatescore 21.4 · 14 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
*	K963618	Synthes Simple Small External Fixator (Ssef) Summary page 1 …0 Russell Road Paoli, PA 19301 (610) 647-9700 Angela J. Silvestri External Fixation Frame Class I1, 21 CFR 888.3030; 888:3040 Synthes Simple Small External Fixatior (K963618) Hand Biomechanics Lab-Agee-WristJack (K942906) Biomet Inc, Hammer Mini-Tubular External Fixation Device (K982982) The Articula…	Synthes (Usa)	1996	—
*	K942906	Agee-Wristjack Pre-Drill Kit Summary page 1 …ngela J. Silvestri External Fixation Frame Class I1, 21 CFR 888.3030; 888:3040 Synthes Simple Small External Fixatior (K963618) Hand Biomechanics Lab-Agee-WristJack (K942906) Biomet Inc, Hammer Mini-Tubular External Fixation Device (K982982) The Articulating Distal Radius Fixator is a preassembled mec…	Hand Biomechanics Lab, Inc.	1994	—
*	K982982	Mini-Fixator for Colles Fractures Summary page 1 …030; 888:3040 Synthes Simple Small External Fixatior (K963618) Hand Biomechanics Lab-Agee-WristJack (K942906) Biomet Inc, Hammer Mini-Tubular External Fixation Device (K982982) The Articulating Distal Radius Fixator is a preassembled mechanically adjustable external wrist fixator. It is a one-piece cons…	Biomet, Inc.	1998	—

Also cleared against K963618: 2 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K012294	Wristore Fixator	Millennium Medical Technologies, Inc.	2002	3
K020311	Clearview Wrist Fixator	Rigid FX Orthopedics, Incorporated	2002	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 3 ancestors has a recall.
Of its descendants, K012294 (Millennium Medical Technologies, Inc., 2002) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K963618.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.

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/K984498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984498

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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