510(k) · Cleared

Cleared

K2 Bone Screw System

K960537510(k) TraditionalCleared Mar 25, 199647-day reviewClass II21 CFR 888.3040

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

Kinetikos Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 25, 1996 as substantially equivalent to K903810 (Ace Medical Co., 1990) and 6 other predicates after a 47-day review. Its family tree reaches back 1 generation to 1979. 41 later devices descend from it.

Decided: Mar 25, 1996
Review: 47 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K792022 (1979). 7 ancestors in all. 41 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
This deviceK960537 K2 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
Descendant · 4 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1997high 8 (2022) · low 0 (1998)2026

Most influential descendants

Showing 5 of 41 · See all

K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 4 generations on9descendants
K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792022	Herbert Bone Screw	Zimmer, Inc.	1979	6
0 (this device)	K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+1	K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	1
+2	K123890	Acumed Cannulated Screw System	Acumed, LLC	2013	2
+3	K190586	Monster® Screw System	Paragon 28, Inc.	2019	—
+4	K200398	AxSOS 3 AF System and AxSOS 3 Ti System	Stryker GmbH	2020	—
+2	K150693	PHIN-FX Cannulated Lag Screw System	Ascent Medical, LLC	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1990	1	0
1992	1	0
1993	1	0
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2012	1	0
2013	1	0
2015	1	0
2017	3	0
2019	3	0
2020	5	0
2021	1	0
2022	8	0
2023	7	0
2024	3	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K960537, 1979–2026Source: 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

Get a 510(k) Report

What was it cleared against? (9)

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
*	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw Summary page 3 …ces: This product 1s substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & J…	Ace Medical Co.	1990	—
*	K921622	Alphatec Compression Hip Screw System Summary page 3 …tantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturi…	Alphatec Mfg., Inc.	1992	—
*	K931524	Fully Threaded Alta Cancellous Bone Screw Summary page 3 …t in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturing K? The KMI K2 B…	Howmedica Corp.	1994	—
*	K940207	Titanium Alloy Bone Screws Summary page 3 …sition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturing K? The KMI K2 Bone Screw System™…	Aesculap, Inc.	1994	—
*	K924018	M3 Lag Screw Fixation System Summary page 3 …n to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturing K? The KMI K2 Bone Screw System™ meet the ASTM stan…	Osteomed Corp.	1993	—
*	K792022	Herbert Bone Screw Summary page 3 …pedic screws manufactured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturing K? The KMI K2 Bone Screw System™ meet the ASTM standards (ASTM B348…	Zimmer, Inc.	1979	6
*	K792291	Synthes Reconstructive Plates 'Y' Plates Summary page 3 …ured and approved for market. Ace Medical Company: K903810 Alphatec Medical: K921622 Howmedica: K931524 Aesculap: K940207 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Johnson & Johnson K? ISI Manufacturing K? The KMI K2 Bone Screw System™ meet the ASTM standards (ASTM B348-83, F136- 84, F67-88…	Synthes (Usa)	1979	—
*	—	Johnson & Johnson Named without a submission number			—
*	—	ISI Manufacturing Named without a submission number			—

Also cleared against K903810: 11 other devices →

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	39
K972217	Orthopedic Screw System	Ferguson Medical	1997	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?

1 of the 7 ancestors has a recall of any class.
Of its descendants, K120493 (Instratek, Inc., 2012) has gone furthest, with 39 descendants of its own.
11 other devices also cite its predicate K903810.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.

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/K960537 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960537: K2 Bone Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960537

Report an extraction error

Are you the manufacturer?

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