510(k) Report

510(k) · Cleared

Cleared

Bone Suture Fixation Device

K880264510(k) TraditionalCleared Mar 23, 198861-day reviewClass I21 CFR 888.4540

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

Orthopedic Systems, Inc. · HXY Brace, Drill

Cleared on Mar 23, 1988 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 23, 1988
Review
61 days
Class
Class I
Product code
HXY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K880264Source: 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.

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  • 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 HXY devices

HXY Brace, Drill: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXY

FDA has decided no HXY device since 2007.

Median 510(k) review, days · HXY

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

Recalls per year · HXY

No recall names HXY since 2007.

Adverse event reports per year · HXY

1in 2021

2007: 42008: 12009: 12010: 12011: 32016: 12019: 12021: 1
2007high 4 (2007) · low 0 (2012)2025

MAUDE reports naming product code HXY, 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—04
20080—01
20090—01
20100—01
20110—03
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—01
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
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

Recent decisions in HXY

The HXY category page

  • K923776Benderev Drill GuideNeimark Labs, Inc. · 1992
  • K892904Mitek Drill GuideMitek Surgical Products, Inc. · 1989
  • K880381Telos Distal Targeting DeviceAustin Assoc. · 1988
  • K880046Hasting Finger Fixator InstrumentsBuckman Co., Inc. · 1988
  • K831043Andrews Remote Chuck DrillOrthopedic Systems, Inc. · 1983

https://510kreport.com/device/K880264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880264: Bone Suture Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880264

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