510(k) Report

510(k) · Cleared

Cleared

Scoliometer

K832494510(k) TraditionalCleared Aug 16, 198320-day review

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

Orthopedic Systems, Inc.

Cleared on Aug 16, 1983 after a 20-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
Aug 16, 1983
Review
20 days
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared19801990200020102020
  1. This deviceK832494 ScoliometerOrthopedic Systems, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK011827 Ortelius 800Orthoscan, Ltd. · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K011827Ortelius 800Orthoscan, Ltd. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832494ScoliometerOrthopedic Systems, Inc.1983—
+1K011827Ortelius 800Orthoscan, Ltd.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K832494, 1983–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 this category? 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
Get a 510(k) Report

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
K011827Ortelius 800Orthoscan, Ltd.20010

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, K011827 (Orthoscan, Ltd., 2001) has gone furthest, with 0 descendants of its own.

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/K832494 · printed Nov 5, 2026

Cite this page

510(k) Report. “K832494: Scoliometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K832494

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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