510(k) Report

510(k) · Cleared

Cleared

C-S Impactor

K890185510(k) TraditionalCleared Apr 6, 198978-day reviewClass II21 CFR 888.3050

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

Orthopedic Systems, Inc. · LYP Accessories, Fixation, Spinal Interlaminal

Cleared on Apr 6, 1989 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 6, 1989
Review
78 days
Class
Class II
Product code
LYP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890185Source: FDA 510(k) database · 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.

Planning a device in LYP? 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?

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

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.

How does its category compare?

All LYP devices

LYP Accessories, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYP

FDA has decided no LYP device since 2007.

Median 510(k) review, days · LYP

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

Recalls per year · LYP

No recall names LYP since 2007.

Adverse event reports per year · LYP

2in 2025

2014: 12024: 12025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code LYP, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—02
20260—0—

More from Orthopedic Systems, Inc.

95 FDA decisions under this applicant name. See the company

  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K920256Spine Motion Analyzer with EmgOrthopedic Systems, Inc. · 1992
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K910031Park City Shoulder PositionerOrthopedic Systems, Inc. · 1991
  • K903938C Fit CupOrthopedic Systems, Inc. · 1991

https://510kreport.com/device/K890185 · printed Nov 3, 2026

Cite this page

510(k) Report. “K890185: C-S Impactor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K890185

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026