510(k) Report

510(k) · Cleared

Cleared

Compass (TM) Stereotactic Retractor System

K896156510(k) TraditionalCleared Dec 6, 198943-day reviewClass II21 CFR 882.4800

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

Stereotactic Medical Systems, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery

Cleared on Dec 6, 1989 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.

Decided
Dec 6, 1989
Review
43 days
Class
Class II
Product code
GZT
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared, 1 with a Class I recall12021: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2019: 2 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK896156 Compass (TM) Stereotactic Retractor SystemStereotactic Medical Systems, Inc. · 1989
  2. Descendant · cites it directly · 10 of its ownK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
  3. Descendant · 2 generations on · 8 of its ownK120691 Brain PortNico Corporation · 2012 · Recalled
  4. Descendant · 3 generations on · 4 of its ownK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
  5. Descendant · 4 generations on · 3 of its ownK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
  6. Descendant · 5 generations on · 2 of its ownK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006: 12012: 12015: 12017: 12019: 22020: 22021: 12023: 12025: 1
2006high 2 (2019) · low 0 (2007)2026

Class I recalls in this family

  • K060973 Vycor Surgical Access Systemscites it directly · 2006

Most influential descendants

Showing 5 of 11 · See all
  • K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · cites it directly10descendants
  • K120691Brain PortNico Corporation · 2012 · 2 generations on8descendants
  • K182211Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019 · 3 generations on4descendants
  • K191861Aurora Surgiscope SystemRebound Therapeutics · 2019 · 4 generations on3descendants
  • K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics · 2020 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896156Compass (TM) Stereotactic Retractor SystemStereotactic Medical Systems, Inc.1989—
+1K060973Vycor Surgical Access SystemsVycor Medical, LLC2006Class I
+2K120691Brain PortNico Corporation20122
+3K182211Aurora Surgiscope SystemRebound Therapeutics Corporation2019—
+4K191861Aurora Surgiscope SystemRebound Therapeutics2019—
+5K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control…Rebound Therapeutics20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200611
201210
201510
201710
201920
202020
202110
202310
202510
FIG. 1 — Lineage of K896156, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has a Class I recall. 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 GZT device

  1. #1 K252995 Durashield Device Kitscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K060973Vycor Surgical Access Systems Class IVycor Medical, LLC200610

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K060973 (Vycor Medical, LLC, 2006) has gone furthest, with 10 descendants of its own.

How does its category compare?

All GZT devices

GZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZT

1in 2022

2007: 22009: 12010: 12011: 12012: 22015: 12016: 12017: 32018: 12020: 12021: 12022: 12026 (partial year): 1
2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZT

280in 2017

2017: 280 days median
2007high 280 (2017)2026

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

Recalls per year · GZT

1in 2012

2007: 12012: 1, 1 Class I
2007high 1 (2007) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GZT

1in 2025

2009: 12010: 42011: 42012: 62013: 122014: 162015: 42016: 52017: 92018: 32019: 52020: 32021: 22022: 42023: 22024: 82025: 1
2007high 16 (2014) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—10
20080—00
20091—01
20101—04
20111—04
20122—1 (1)6
20130—012
20140—016
20151—04
20161—05
2017328009
20181—03
20190—05
20201—03
20211—02
20221—04
20230—02
20240—08
20250—01
20261—0—

More from Stereotactic Medical Systems, Inc.

5 FDA decisions under this applicant name. See the company

  • K884415EP-100 (Series)Stereotactic Medical Systems, Inc. · 1989
  • K883653EP-100 Infusion PumpStereotactic Medical Systems, Inc. · 1988
  • K871046Compass Stereotactic Positioning SystemStereotactic Medical Systems, Inc. · 1987
  • K862220Compass CT Stereotactic Adaptation SystemStereotactic Medical Systems, Inc. · 1986

Recent decisions in GZT

The GZT category page

  • K252995Durashield Device KitSurGenTec, LLC · 2026
  • K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc. · 2022
  • K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the…Vycor Medical, Inc. · 2021
  • K202072MindsEye Expandable PortMinnetronix Neuro, Inc. · 2020
  • K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018

https://510kreport.com/device/K896156 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896156: Compass (TM) Stereotactic Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896156

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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