510(k) · Cleared

Cleared

Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS

K033112510(k) TraditionalCleared Nov 5, 200336-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

Hand Biomechanics Lab, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 5, 2003 as substantially equivalent to K984442 (Hand Biomechanics Lab, Inc., 1999) after a 36-day review. Its family tree reaches back 2 generations to 1985.

Decided: Nov 5, 2003
Review: 36 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K842493 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK842493 Agee External FixatorThe Hand Biomechanics Research Laboratory · 1985
1 generation backK984442 Agee-Wristjack Fracture Reaction System (Sterile Version), Model…Hand Biomechanics Lab, Inc. · 1999 · Recalled
This deviceK033112 Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models…Hand Biomechanics Lab, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K842493	Agee External Fixator	The Hand Biomechanics Research Laboratory	1985	—
−1	K984442	Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147	Hand Biomechanics Lab, Inc.	1999	1
0 (this device)	K033112	Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347…	Hand Biomechanics Lab, Inc.	2003	—

FIG. 1 — Lineage of K033112, 1985–2003Source: 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 21.3 · 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? (1)

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
*	K984442	Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 Summary page 1 …andards: No performance standards exist for this device. Predicate Device: Agee WristJack Fracture Reduction System (sterile), Item No. CFD-147, K984442 Description of Device: The WristJack ORlF System i s an external fixation system used for reduction and fixat…	Hand Biomechanics Lab, Inc.	1999	1

Also cleared against K984442: 1 other device →

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 18 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K984442.

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?

Fracture reduction and external fixation for treatment of distal radius fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033112: Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033112

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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