510(k) · Cleared

Cleared

Aesculap Pneumatic Kerrison

K062413510(k) TraditionalCleared Nov 21, 200696-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

Cleared on Nov 21, 2006 as substantially equivalent to K980686 (Aesculap, Inc., 1998) and 1 other predicate after a 96-day review. Its family tree reaches back 2 generations to 1997.

Decided: Nov 21, 2006
Review: 96 days
Class: Class II
Product code: HAD
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K973736 (1997). 6 ancestors in all, the oldest K831756 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973736 Aesculap Hilan Motor SystemAesculap, Inc. · 1997
1 generation backK980686 Aesculap Hilan Motor SystemAesculap, Inc. · 1998
This deviceK062413 Aesculap Pneumatic KerrisonAesculap, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973736	Aesculap Hilan Motor System	Aesculap, Inc.	1997	—
−1	K980686	Aesculap Hilan Motor System	Aesculap, Inc.	1998	—
0 (this device)	K062413	Aesculap Pneumatic Kerrison	Aesculap, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1997	1	0
2001	1	0
2002	1	0

FIG. 1 — Lineage of K062413, 1997–2006Source: 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
*	K980686	Aesculap Hilan Motor System Summary page 1 …HAD SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Pneumatic Kerrison is substantially equivalent to: * Aesculap Hil-an Motor System by Aesculap Inc. (K980686) * Aesculap manual Kerrisons by Aesculap Inc. (Class I device) * Anspach Powered Kerrison System (PKS) by The Anspach Eff…	Aesculap, Inc.	1998	—
*	K022907	Anspach Powered Kerrison System (PKS) Summary page 1 …y Aesculap Inc. (K980686) * Aesculap manual Kerrisons by Aesculap Inc. (Class I device) * Anspach Powered Kerrison System (PKS) by The Anspach Effort, Inc (K022907) DEVICE DESCRIPTION The Aesculap Pneumatic Kerrison is powered by pneumatic pressure. The power is supplied by compressed air th…	The Anspach Effort, Inc.	2002	—
*	—	Aesculap manual Kerrisons Named without a submission number			—

Also cleared against K980686: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 1 company; a new generation was cleared every 8.2 years on median.
3 of the 6 ancestors have a recall of any class.
3 other devices also cite its predicate K980686.

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?

Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery and othopaedics).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062413: Aesculap Pneumatic Kerrison.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062413

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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