510(k) · Cleared

Recalled · Class II · 2017

Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)

K091694510(k) SpecialCleared Jul 7, 200927-day reviewClass II21 CFR 888.3040Recalls 5

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

Tag Medical Products · HWC Screw, Fixation, Bone

Cleared on Jul 7, 2009 as substantially equivalent to K083096 (Tag Medical Products, 2009) after a 27-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it. It has been recalled 5 times.

Decided: Jul 7, 2009
Review: 27 days
Class: Class II
Product code: HWC
Recalls: 5
Predicates: 1

Its longest line of descent runs back 2 generations to K903811 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK903811 Ace Cannulated Cortical Bone ScrewAce Medical Co. · 1990
1 generation backK083096 Latarjet Cortical Screw SetTag Medical Products · 2009 · Recalled
This deviceK091694 Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J…Tag Medical Products · 2009
Descendant · cites it directly · 1 of its ownK110763 Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK253858 GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026

Most influential descendants

Showing 2 of 2 · See all

K110763Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011 · cites it directly1descendant
K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903811	Ace Cannulated Cortical Bone Screw	Ace Medical Co.	1990	—
−1	K083096	Latarjet Cortical Screw Set	Tag Medical Products	2009	5
0 (this device)	K091694	Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)	Tag Medical Products	2009	—
+1	K110763	Latarjet Cortical Screw Set	T.A.G. Medical Products Corporation, Ltd.	2011	5
+2	K253858	GFS - Sterile Screws and Top Hat	T.A.G. Medical Products Corporation, Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2026	1	0

FIG. 1 — Lineage of K091694, 1990–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 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
*	K083096	Latarjet Cortical Screw Set Summary page 1 …Fixation Screw, class IIdevice (product code HWC). Name: Latarjet Cortical Screw Set 3. Predicate Device: The Latarjet Cortical Screw Set K083096 4. Description: The Latarjet Cortical Screw Set consists of an implantable fixation screw…	Tag Medical Products	2009	5

Also cleared against K083096: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K110763	Latarjet Cortical Screw Set	T.A.G. Medical Products Corporation, Ltd.	2011	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2017	Class II	Z-2618-2017	Component design/selection	Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
May 12, 2017	Class II	Z-2615-2017	Component design/selection	Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
May 12, 2017	Class II	Z-2619-2017	Component design/selection	Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
May 12, 2017	Class II	Z-2616-2017	Component design/selection	Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
May 12, 2017	Class II	Z-2617-2017	Component design/selection	Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 18.5 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K110763 (T.A.G. Medical Products Corporation, Ltd., 2011) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K083096.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Latarjet Cortical Screw Set is intended to provide the

orthopedic surgeon a means of bone fixation and to assist in the management of

fractures and reconstructive surgeries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091694 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091694: Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091694

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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