510(k) · Cleared
ClearedContour II Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altiva Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 13, 2006 as substantially equivalent to K971457 (Arcan Orthopaedic Corp., 1997) and 2 other predicates after a 104-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 13, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all, the oldest K962784 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK053070 Contour II Spinal SystemAltiva Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K053070 | Contour II Spinal System | Altiva Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K971457 | Bryan Posterior Spinal Fixator (BPSF), ModifiedSummary page 4…888.3060 Spinal Interlaminal Fixation Orthosis, (KWP) per 21 CFR 888.3050 VI. PREDICATE DEVICES: Arcan Orthopedics, Contour Spinal Fixation System (K971457) Class I1 Decision Date: July 16, 1997 (and) U & I Corporation, Optima Spinal System (K031585)… | 1997 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 4…rthopedics, Contour Spinal Fixation System (K971457) Class I1 Decision Date: July 16, 1997 (and) U & I Corporation, Optima Spinal System (K031585) Class II Decision Date: June 27, 2003 (and) Ultium Spinal Plating System, Altiva Corporation (K9… | 2003 |
| * | K962784 | Ultium Spinal Plating SystemSummary page 4…Corporation, Optima Spinal System (K031585) Class II Decision Date: June 27, 2003 (and) Ultium Spinal Plating System, Altiva Corporation (K962784) Class I1 Decision Date: October 2, 1996 VII. SUBSTANTIAL EQUIVALENCE CONCLUSIONS: Aitiva conclude… | 1996 |
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 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
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?
The CONTOUR IITM Spinal System is intended for noncervical, pedicle fixation 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis…
Read the full statement (245 words)
The CONTOUR IITM Spinal System is intended for noncervical, pedicle fixation 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, the CONTOUR IITM Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
The CONTOUR IITM Spinal System (KWP) is also intended for use as a posterior noncervical, ilonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogeilic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
When used as an anterior fixation system, the CONTOUR IITM Spinal System (KWQ) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history .and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053070: Contour II Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053070
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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