510(k) · Cleared

Cleared

Stryker Hip Arthoroscopy Set

K982375510(k) TraditionalCleared Oct 2, 199887-day reviewClass II21 CFR 888.1100

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

Cleared on Oct 2, 1998 as substantially equivalent to K963524 (Karl Storz Endoscopy, 1996) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it.

Decided: Oct 2, 1998
Review: 87 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K833587 (1983). 15 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
2 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
1 generation backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
This deviceK982375 Stryker Hip Arthoroscopy SetStryker Endoscopy · 1998
Descendant · cites it directly · 0 of its ownK012635 Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001 · Recalled
Descendant · cites it directly · 0 of its ownK012605 Reprocessed Athroscopics BursAlliance Medical Corp. · 2001 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001 · cites it directly0descendants
K012605Reprocessed Athroscopics BursAlliance Medical Corp. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K833587	Disposable Arthroscopy Blade	Dyonics, Inc.	1983	—
−2	K900070	Modified Uses of the Arthroscopic Surgical System	Dyonics, Inc.	1990	—
−1	K971253	Various Arthroscopes, Endoscopic Blades, Manual Instruments	Smith & Nephew, Inc.	1997	—
0 (this device)	K982375	Stryker Hip Arthoroscopy Set	Stryker Endoscopy	1998	—
+1	K012635	Reprocessed Stryker Arthroscopic Shavers	Alliance Medical Corp.	2001	8
+1	K012605	Reprocessed Athroscopics Burs	Alliance Medical Corp.	2001	9

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1988	1	0
1990	1	0
1991	1	0
1992	1	0
1994	2	0
1995	2	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

FIG. 1 — Lineage of K982375, 1983–2001Source: 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 HRX? 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 HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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
*	K963524	Ksea Large Joint Arthroscopy Set Summary page 1 …ial Equivalence Statement: Stryker hip arthroscopes are claimed substantially equivalent (SE) to commercially available arthroscopes made by Karl Storz and cleared under K963524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex,…	Karl Storz Endoscopy	1996	—
*	K971253	Various Arthroscopes, Endoscopic Blades, Manual Instruments Summary page 1 …and cleared under K963524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex, cleared under K971253, K963524, and K926212 respectively. Safety and Effectiveness: The Hip Arthroscopy Set is made size length appropriate, reflectin…	Smith & Nephew, Inc.	1997	—
*	K926212	Arthrex Instruments ( Hip ) Summary page 1 …524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex, cleared under K971253, K963524, and K926212 respectively. Safety and Effectiveness: The Hip Arthroscopy Set is made size length appropriate, reflecting desirable characteri…	Arthrex, Inc.	1994	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K012635	Reprocessed Stryker Arthroscopic Shavers	Alliance Medical Corp.	2001	0
K012605	Reprocessed Athroscopics Burs	Alliance Medical Corp.	2001	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?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
None of the 15 ancestors has a recall.
Of its descendants, K012635 (Alliance Medical Corp., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

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/K982375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982375: Stryker Hip Arthoroscopy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982375

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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