510(k) · Cleared

Cleared

Various Arthroscopes, Endoscopic Blades, Manual Instruments

K971253510(k) TraditionalCleared Jun 13, 199771-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 Jun 13, 1997 as substantially equivalent to K771218 (Dyonics, Inc., 1978) and 11 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1983. 60 later devices descend from it.

Decided: Jun 13, 1997
Review: 71 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 13

Its longest line of descent runs back 2 generations to K833587 (1983). 12 ancestors in all, the oldest K771218 (1978). 60 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
1 generation backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
This deviceK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
Descendant · cites it directly · 32 of its ownK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
Descendant · 2 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
Descendant · 2 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
Descendant · cites it directly · 21 of its ownK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
Descendant · 2 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

1998high 5 (2014) · low 0 (1999)2026

Most influential descendants

Showing 5 of 60 · See all

K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005 · cites it directly32descendants
K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 2 generations on30descendants
K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 2 generations on21descendants
K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008 · cites it directly21descendants
K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · 2 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K833587	Disposable Arthroscopy Blade	Dyonics, Inc.	1983	—
−1	K900070	Modified Uses of the Arthroscopic Surgical System	Dyonics, Inc.	1990	—
0 (this device)	K971253	Various Arthroscopes, Endoscopic Blades, Manual Instruments	Smith & Nephew, Inc.	1997	—
+1	K043395	Smith & Nephew Videoarthroscope	Smith & Nephew, Inc.	2005	—
+2	K072879	Innervue Diagnostic Scope System	Biomet Orthopedics, Inc.	2008	2
+2	K082293	Surgview Integrated Visualization System	Biovision Technologies, LLC	2008	—
+1	K080560	Henke Sass Wolf of America Arthroscope	Henke Sass Wolf of America, Inc.	2008	—
+2	K093717	C-Mor Visualization Device	Axis Surgical Technologies, Inc.	2010	—

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	1	0
1995	2	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	4	0
2005	1	0
2007	1	0
2008	3	0
2010	3	0
2011	3	0
2012	3	0
2013	1	0
2014	5	0
2015	4	0
2016	4	0
2017	1	0
2018	3	0
2019	4	0
2020	3	0
2021	4	0
2022	3	0
2023	1	0
2024	3	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K971253, 1983–2026Source: 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 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

Get a 510(k) Report

What was it cleared against? (13)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K771218	Intra-Articular Shaver Summary page 1 …ices in this 510(k) submission were originally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Sum…	Dyonics, Inc.	1978	—
*	K820367	Intra-Articular Surgical System Summary page 1 …is 510(k) submission were originally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of De…	Dyonics, Inc.	1982	—
*	K880150	Pacesetter (TM) 3500 Arthroscopic Surgical System Summary page 1 …submission were originally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Funct…	Dyonics, Inc.	1988	—
*	K914559	Small Joint System Summary page 1 …were originally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The…	Smith & Nephew Dyonics, Inc.	1992	—
*	K961228	Karl Storz Magnifying Arthrosocpes Summary page 1 …inally reviewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & N…	KARL STORZ Endoscopy-America, Inc.	1996	—
*	K954989	Dyonics Disposable Endoscopic Surgery Blades Summary page 1 …iewed and determined to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc…	Smith & Nephew Dyonics, Inc.	1995	—
*	K904284	Arthroscopic Surgical Blade Summary page 1 …scopic Surgery Blades are similar to product currently marketed under 510(k) #K900070. Manual Instruments are longer versions of product currently marketed under 510(k) #K904284 or those that are Class \|, exempt devices. Predicate Device : The devices in this 510(k) submission were originally reviewed an…	Smith & Nephew Dyonics, Inc.	1990	—
*	K953695	Dyonics Disposable Arthroscopic Blades Summary page 1 …to be substantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc., Endoscopy Divisio…	Smith & Nephew Dyonics, Inc.	1995	—
Kept off the family tree	K941038	Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …stantially equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc., Endoscopy Division Arthrosc…
*	K934299	Dyonics Disposable Arthroscopic Surgery Blades Modification Summary page 1 …equivalent to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and A…	Smith & Nephew Dyonics, Inc.	1994	—
*	K912453	Intelijet TM Fluid Management System Summary page 1 …t to a predicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories…	Smith & Nephew Dyonics, Inc.	1991	—
*	K833587	Disposable Arthroscopy Blade Summary page 1 …dicate device under one or more of the following 510(k)s : #K771218, #K820367, #K880150, #K914559, #K961228, #K954989, #K904284, #K953695, #K941038, #K934299, #K912453, #K833587, and #K900070. Summary of Device Function : The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are to be…	Dyonics, Inc.	1983	—
*	K900070	Modified Uses of the Arthroscopic Surgical System Summary page 1 …iate for use within the hip joint as well as all other previously approved indications. Endoscopic Surgery Blades are similar to product currently marketed under 510(k) #K900070. Manual Instruments are longer versions of product currently marketed under 510(k) #K904284 or those that are Class \|, exempt dev…	Dyonics, Inc.	1990	—

Also cleared against K771218: 6 other devices →

What descends from it? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K043395	Smith & Nephew Videoarthroscope	Smith & Nephew, Inc.	2005	32
K080560	Henke Sass Wolf of America Arthroscope	Henke Sass Wolf of America, Inc.	2008	21
K982375	Stryker Hip Arthoroscopy Set	Stryker Endoscopy	1998	2
K012652	Reprocessed Dyonics Arthroscopic Burs	Alliance Medical Corp.	2001	0
K012611	Reprocessed Dyonics Arthroscopic Shavers	Alliance Medical, Inc.	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 14 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
None of the 12 ancestors has a recall.
Of its descendants, K043395 (Smith & Nephew, Inc., 2005) has gone furthest, with 32 descendants of its own.
6 other devices also cite its predicate K771218.

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 Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist and jaw, also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate. The Smith & Nephew, Inc.…

Read the full statement (117 words)

The Smith & Nephew, Inc., Endoscopy Division sterile, disposable Endoscopic Surgery Blades as indicated for use during arthroscopic resection of soft and osseous tissue in various large and small articular cavities including the hip joint. Blades which are size-appropriate are indicated for use in the following joints : shoulder, knee, elbow, ankle, wrist, jaw and the hip joint.

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/K971253 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971253: Various Arthroscopes, Endoscopic Blades, Manual Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971253

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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