510(k) · Cleared
Cleared5.0MM Spinal Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Tec, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Apr 10, 2000 as substantially equivalent to K983353 (Orthotec, Inc., 1998) after a 112-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Apr 10, 2000
- Review
- 112 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901587 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 1 generation backK983353 SCS Spinal SystemOrthotec, Inc. · 1998
- This deviceK994288 5.0MM Spinal ScrewsOrtho Tec, LLC · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K983353 | SCS Spinal System | Orthotec, Inc. | 1998 | — |
| 0 (this device) | K994288 | 5.0MM Spinal Screws | Ortho Tec, LLC | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
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 MNH? 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
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 | Decided |
|---|---|---|---|
| * | K983353 | SCS Spinal SystemSummary page 1…I, respectively 4, Equivalent Predicate Device: The 5.0mm Spinal Screws may be directly contrasted with the larger diameter cleared spinal screws of SCS Spinal System, K983353. Other than the reduced major screw diameter, the §.0mm Spinal Screws are essentially the same as the cleared spinal screws in th… | 1998 |
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?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 16 ancestors has a recall.
- 1 other device also cites its predicate K983353.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: 1. degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, fordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) used as an anterolateral/anterior system the SCS system is…
Read the full statement (235 words)
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
1. degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, fordosis)
tumors
pseudarthrosis
failed previous fusion (pseudarthrosis)
used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:
1. having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
2. receiving fusions using autogenous bone graft only
3. having the device fixed or attached to the lumbar and sacral spine
4. having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
1. degenerative spondylolisthesis with objective evidence of neurologic impairment
2. fracture
3. dislocation
4. scoliosis
5. kyphosis
6. spinal tumor
7. failed previous fusion (pseudarthrosis)
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/K994288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994288: 5.0MM Spinal Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994288
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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