510(k) Report

510(k) · Cleared

Cleared

Ems Swiss Orthoclast

K991588510(k) TraditionalCleared Jul 21, 199975-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

(Ems Sa) Electro Medical Systems · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Cleared on Jul 21, 1999 as substantially equivalent to K933933 (Synvasive Technology, Inc., 1994) after a 75-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jul 21, 1999
Review
75 days
Class
Class I
Product code
HSZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K933933 (1994). No later device cites it as a predicate yet.

K933933 · Ceboplane · Synvasive Technology, Inc. · 1994199019921994199619982000
K933933 · Ceboplane · Synvasive Technology, Inc. · 19940
  1. Root · 1 generation backK933933 CeboplaneSynvasive Technology, Inc. · 1994
  2. This deviceK991588 Ems Swiss Orthoclast(Ems Sa) Electro Medical Systems · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933933CeboplaneSynvasive Technology, Inc.1994—
0 (this device)K991588Ems Swiss Orthoclast(Ems Sa) Electro Medical Systems1999—
FIG. 1 — Lineage of K991588, 1994–1999Source: 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K933933Ceboplane
Summary page 1
…ual Name: Powered orthopedic surgical instrument Classification Name: Instrument, surgical, orthopedic, pneumatic powered and accessories PREDICATE DEVICE Ceboplane® (K933933) INTENDED USE The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery. DEVICE DESCRIPTION…
Synvasive Technology, Inc.1994—

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.

What does this lineage say?

  • Its one ancestor has no recall.

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—

What is it indicated for?

The EMS Swiss OrthoClast® is used for the removal of cement during implant revision surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from (Ems Sa) Electro Medical Systems

5 FDA decisions under this applicant name. See the company

  • K073284Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
  • K032099Swiss Master Light(Ems Sa) Electro Medical Systems · 2003
  • K992504Ems Kermit(Ems Sa) Electro Medical Systems · 2000
  • K991874Ems Surface Mount Scaler(Ems Sa) Electro Medical Systems · 1999

Recent decisions in HSZ

The HSZ category page

  • 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
  • K944590Ethicon Drill Bit and Drill GuideETHICON, Inc. · 1995

https://510kreport.com/device/K991588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991588: Ems Swiss Orthoclast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991588

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026