510(k) Report

510(k) · Cleared

Cleared

Arthroscopic Meniscal Suture System

K871323510(k) TraditionalCleared May 1, 198728-day reviewClass I21 CFR 888.4800

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

Orthopedic Systems, Inc. · HWT Template

Cleared on May 1, 1987 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 1, 1987
Review
28 days
Class
Class I
Product code
HWT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K871323Source: 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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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 HWT devices

HWT Template: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWT

FDA has decided no HWT device since 2007.

Median 510(k) review, days · HWT

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

Recalls per year · HWT

1in 2017

2008: 62010: 132013: 32014: 12017: 1
2007high 13 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWT

2,216in 2025

2008: 52010: 622011: 22012: 202013: 882014: 782015: 932016: 4442017: 6512018: 7142019: 7412020: 9382021: 2,1772022: 2,0962023: 2,5982024: 2,4162025: 2,216
2007high 2,598 (2023) · low 0 (2007)2025

MAUDE reports naming product code HWT, 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—65
20090—00
20100—1362
20110—02
20120—020
20130—388
20140—178
20150—093
20160—0444
20170—1651
20180—0714
20190—0741
20200—0938
20210—02,177
20220—02,096
20230—02,598
20240—02,416
20250—02,216
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 HWT

The HWT category page

  • K974406OrthoplanOrtho-Graphics, Inc. · 1998
  • K960685Orthodoc Preoperative Planner Model 500Integrated Surgical Systems, Inc. · 1997
  • K894228Kronner Spherical CuttersKronner Medical · 1990
  • K870843Schultz Phalangeal Comp Trial/Metacarpal Comp TriaWarsaw Orthopedic, Inc. · 1987
  • K8303603M Osteotomy Guide3M Company · 1983

https://510kreport.com/device/K871323 · printed Nov 4, 2026

Cite this page

510(k) Report. “K871323: Arthroscopic Meniscal Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871323

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