510(k) Report

510(k) · Cleared

Cleared

Harrington Spinal Elevator

K781449510(k) TraditionalCleared Sep 27, 197835-day reviewClass I21 CFR 878.4800

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

Orthopedic Equipment Co., Inc. · GEG Elevator, Surgical, General & Plastic Surgery

Cleared on Sep 27, 1978 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Sep 27, 1978
Review
35 days
Class
Class I
Product code
GEG
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK781449 Harrington Spinal ElevatorOrthopedic Equipment Co., Inc. · 1978
  2. Descendant · cites it directly · 3 of its ownK161028 K2M Growing Spine SystemK2m, Inc. · 2016
  3. Descendant · 2 generations on · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
  4. Descendant · 3 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
  5. Descendant · 3 generations on · 0 of its ownK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022

Most influential descendants

Showing 4 of 4 · See all
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016 · cites it directly3descendants
  • K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · 2 generations on2descendants
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 3 generations on0descendants
  • K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K781449Harrington Spinal ElevatorOrthopedic Equipment Co., Inc.1978—
+1K161028K2M Growing Spine SystemK2m, Inc.2016—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.2018—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System…Globus Medical, Inc.2026—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
202210
202610
FIG. 1 — Lineage of K781449, 1978–2026Source: 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 GEG? 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K161028K2M Growing Spine SystemK2m, Inc.20163

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, K161028 (K2m, Inc., 2016) has gone furthest, with 3 descendants of its own.

How does its category compare?

All GEG devices

GEG Elevator, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEG

FDA has decided no GEG device since 2007.

Median 510(k) review, days · GEG

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

Recalls per year · GEG

No recall names GEG since 2007.

Adverse event reports per year · GEG

2in 2024

2008: 22009: 22010: 12012: 12013: 12014: 12016: 12017: 22021: 32022: 22023: 12024: 2
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code GEG, 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—02
20090—02
20100—01
20110—00
20120—01
20130—01
20140—01
20150—00
20160—01
20170—02
20180—00
20190—00
20200—00
20210—03
20220—02
20230—01
20240—02
20250—00
20260—0—

More from Orthopedic Equipment Co., Inc.

45 FDA decisions under this applicant name. See the company

  • K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc. · 1984
  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  • K800530Schlein Tri-Surface AnkleOrthopedic Equipment Co., Inc. · 1980
  • K781445SpreaderOrthopedic Equipment Co., Inc. · 1979
  • K790247Tourniquet Test GageOrthopedic Equipment Co., Inc. · 1979

Recent decisions in GEG

The GEG category page

  • K891894Elevators-Cottle,Mckenty,Goldman,Joseph,ConverseZinnanti Surgical Instruments, Inc. · 1989
  • K891899Elevators, Various TypesZinnanti Surgical Instruments, Inc. · 1989
  • K890365Septum ElevatorKinetic Medical Products · 1989
  • K890230Ligature NeedlesKinetic Medical Products · 1989
  • K890253Surgical ElevatorKinetic Medical Products · 1989

https://510kreport.com/device/K781449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781449: Harrington Spinal Elevator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781449

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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