510(k) · Cleared

Cleared

Osteonics Spinal System-Expanded Indications

K990059510(k) TraditionalCleared Jan 28, 199920-day reviewClass II21 CFR 888.3070

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

Howmedica Osteonics Corp. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jan 28, 1999 as substantially equivalent to K951725 (Osteonics Corp., 1995) after a 20-day review. Its family tree reaches back 1 generation to 1995.

Decided: Jan 28, 1999
Review: 20 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951725 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
This deviceK990059 Osteonics Spinal System-Expanded IndicationsHowmedica Osteonics Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951725	Osteonics Spinal System	Osteonics Corp.	1995	—
0 (this device)	K990059	Osteonics Spinal System-Expanded Indications	Howmedica Osteonics Corp.	1999	—

FIG. 1 — Lineage of K990059, 1995–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MNI? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951725	Osteonics Spinal System Summary page 1 …s® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725. Device Description The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-9…	Osteonics Corp.	1995	—

Also cleared against K951725: 15 other devices →

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.
15 other devices also cite its predicate K951725.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The uses for the legally marketed Osteonics® Spinal System are as follows: As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: Long and short curve scoliosis Vertebral fracture or dislocation Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Previously failed fusion Spinal tumor…

Read the full statement (180 words)

The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

Long and short curve scoliosis

Vertebral fracture or dislocation

Spondylolisthesis

Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Previously failed fusion

Spinal tumor

Pedicular Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, the Osteonics Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below)with removal of the implants after the development of a solid fusion mass.

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

https://510kreport.com/device/K990059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990059: Osteonics Spinal System-Expanded Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990059

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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