510(k) · Cleared

Cleared

Anspach Powered Kerrison System (PKS)

K022907510(k) TraditionalCleared Oct 21, 200248-day reviewClass II21 CFR 882.4845

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

The Anspach Effort, Inc. · HAD Rongeur, Powered

Cleared on Oct 21, 2002 as substantially equivalent to K831756 (The Anspach Effort, Inc., 1983) and 2 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.

Decided: Oct 21, 2002
Review: 48 days
Class: Class II
Product code: HAD
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K831756 (1983). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK831756 Anspach 65,000The Anspach Effort, Inc. · 1983 · Recalled
This deviceK022907 Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc. · 2002
Descendant · cites it directly · 0 of its ownK062413 Aesculap Pneumatic KerrisonAesculap, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K062413Aesculap Pneumatic KerrisonAesculap, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K831756	Anspach 65,000	The Anspach Effort, Inc.	1983	1
0 (this device)	K022907	Anspach Powered Kerrison System (PKS)	The Anspach Effort, Inc.	2002	—
+1	K062413	Aesculap Pneumatic Kerrison	Aesculap, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K022907, 1983–2006Source: 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 HAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K831756	Anspach 65,000 Summary page 2 …ibits). SUBSTANTIAL EQUIVALENCE: The Anspach PKS is a rongeur, powered by a pneumatic (air/gas) or an electric motor currently manufactured and distributed by Anspach (K831756 - Black Max; K965080 - MicroMax and; KO 1 1444 - eMax). Anspach PKS is similar in appearance, materials and has the same intended…	The Anspach Effort, Inc.	1983	1
*	K965080	Anspach Micromax System Summary page 2 …EQUIVALENCE: The Anspach PKS is a rongeur, powered by a pneumatic (air/gas) or an electric motor currently manufactured and distributed by Anspach (K831756 - Black Max; K965080 - MicroMax and; KO 1 1444 - eMax). Anspach PKS is similar in appearance, materials and has the same intended uses as other powere…	The Anspach Effort, Inc.	1997	11
*	K011444	Anspach Emax Drill System	The Anspach Effort, Inc.	2001	70
†	K974025	Anspach Shielded Attachment	The Anspach Effort, Inc.	1998	17

Also cleared against K831756: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K062413	Aesculap Pneumatic Kerrison	Aesculap, Inc.	2006	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?

3 of the 3 ancestors have a recall of any class.
Of its descendants, K062413 (Aesculap, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K831756.

How does its category compare?

All HAD devices

HAD Rongeur, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAD

FDA has decided no HAD device since 2007.

Median 510(k) review, days · HAD

Too few HAD 510(k)s in any year since 2007 to give a median.

Recalls per year · HAD

No recall names HAD since 2007.

Adverse event reports per year · HAD

1in 2022

2007high 15 (2015) · low 0 (2007)2025

MAUDE reports naming product code HAD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	2
2012	—	0
2013	—	1
2014	—	1
2015	—	15
2016	—	10
2017	—	4
2018	—	4
2019	—	0
2020	—	1
2021	—	1
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Anspach Powered Kerrison System® (PKS) is indicated for use as an accessory attachment for Anspach Surgical Motor Systems for cutting, shaping and removal of bone, including bones of the skull and spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022907: Anspach Powered Kerrison System (PKS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022907

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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