510(k) Report

510(k) · Cleared

Cleared

Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-Bits

K880074510(k) TraditionalCleared Mar 25, 198874-day reviewClass I21 CFR 878.4820

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

Romano Surgical Instrumentation, Inc. · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Cleared on Mar 25, 1988 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 25, 1988
Review
74 days
Class
Class I
Product code
HSZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK880074 Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-BitsRomano Surgical Instrumentation, Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK972860 Curvtek TSR SystemBiolectron, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K972860Curvtek TSR SystemBiolectron, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880074Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-BitsRomano Surgical Instrumentation, Inc.1988—
+1K972860Curvtek TSR SystemBiolectron, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K880074, 1988–1997Source: 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.

Planning a device in HSZ? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K972860Curvtek TSR SystemBiolectron, Inc.19970

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?

  • Of its descendants, K972860 (Biolectron, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HSZ devices

HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSZ

FDA has decided no HSZ device since 2007.

Median 510(k) review, days · HSZ

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

Recalls per year · HSZ

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · HSZ

4in 2025

2007: 1112008: 132009: 142010: 112011: 32012: 272013: 4112014: 182015: 202016: 272017: 242018: 132019: 52020: 132021: 272022: 352023: 392024: 72025: 4
2007high 411 (2013) · low 3 (2011)2025

MAUDE reports naming product code HSZ, 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—0111
20080—013
20090—014
20100—011
20110—13
20120—027
20130—1411
20140—018
20150—020
20160—027
20170—024
20180—013
20190—05
20200—013
20210—027
20220—035
20230—039
20240—07
20250—04
20260—0—

More from Romano Surgical Instrumentation, Inc.

2 FDA decisions under this applicant name. See the company

  • K885229Modified Glenoid Arcuate Drill & Disp. Flexi-BitsRomano Surgical Instrumentation, Inc. · 1989

Recent decisions in HSZ

The HSZ category page

  • K991588Ems Swiss Orthoclast(Ems Sa) Electro Medical Systems · 1999
  • K972860Curvtek TSR SystemBiolectron, Inc. · 1997
  • K970345Alignment InstrumentRichard Wolf Medical Instruments Corp. · 1997
  • K955084Aspach 65,000 (Modification)The Anspach Effort, Inc. · 199623 recalls
  • K954080Sodem High Speed SystemSodem Diffusion SA · 1995

https://510kreport.com/device/K880074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880074: Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-Bits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880074

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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