510(k) · Cleared

Cleared

Alphatec Compression Hip Screw System

K921622510(k) TraditionalCleared Jul 2, 199287-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

Alphatec Mfg., Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 2, 1992 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 66 later devices descend from it.

Decided: Jul 2, 1992
Review: 87 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

66 later devices descend from it, 5 citing it directly.

This deviceK921622 Alphatec Compression Hip Screw SystemAlphatec Mfg., Inc. · 1992
Descendant · cites it directly · 61 of its ownK960533 K3 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · cites it directly · 41 of its ownK960537 K2 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · 2 generations on · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
Descendant · 3 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
Descendant · 4 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1996high 9 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 66 · See all

K960533K3 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly61descendants
K960537K2 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly41descendants
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · 2 generations on39descendants
K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 3 generations on36descendants
K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 4 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K921622	Alphatec Compression Hip Screw System	Alphatec Mfg., Inc.	1992	—
+1	K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+1	K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+2	K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	1
+3	K123890	Acumed Cannulated Screw System	Acumed, LLC	2013	2
+4	K190586	Monster® Screw System	Paragon 28, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	1	0
1998	1	0
1999	1	0
2003	1	0
2005	1	0
2012	1	0
2013	3	0
2015	2	0
2016	1	0
2017	6	0
2018	2	0
2019	7	0
2020	6	0
2021	2	0
2022	9	0
2023	9	0
2024	3	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K921622, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	61
K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	41
K990019	DRG Medium Screw System	Dolphin Medical Technologies, Inc.	1999	0
K973810	DRG Large Screw System	Dolphin Medical Technologies, Inc.	1998	0
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?

Of its descendants, K960533 (Kinetikos Medical, Inc., 1996) has gone furthest, with 61 descendants of its own.

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	—

https://510kreport.com/device/K921622 · printed Nov 4, 2026

Cite this page

510(k) Report. “K921622: Alphatec Compression Hip 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/K921622

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026