510(k) · Cleared
ClearedNorm Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 28, 2009 as substantially equivalent to K063708 (Taeyeon Medical Co., Ltd., 2007) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 28, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000319 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK063708 4S Spinal SystemTaeyeon Medical Co., Ltd. · 2007
- This deviceK092011 Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K063708 | 4S Spinal System | Taeyeon Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K092011 | Norm Spinal System | Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K063708 | 4S Spinal SystemSummary page 1…STANTIAL EQUIVALENCE: Norm Spinal System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K063708) and Optima Spinal System (K031585). 2.4 DEVICE DESCRIPTION: Norm Spinal System is a top-loading multiple compo… | 2007 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…l System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K063708) and Optima Spinal System (K031585). 2.4 DEVICE DESCRIPTION: Norm Spinal System is a top-loading multiple component, posterior spinal fixation sys… | 2003 |
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 9 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063708.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). Levels of fixation are for…
Read the full statement (127 words)
NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications of the thoracic, lumbar and sacral spine:
degenerative spondylolisthesis with objective evidence of neurological impairment;
fracture;
dislocation;
scoliosis;
kyphosis;
spinal tumor; and failed previous fusion (pseudarthrosis).
Levels of fixation are for the thoracic, lumbar and sacral spine. Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092011 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092011: Norm Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092011
Report an extraction error
Are you the manufacturer?
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