510(k) · Cleared
ClearedOptima Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 4, 2005 after a 14-day review. The FDA summary names no predicate by number. 387 later devices descend from it.
- Decided
- Aug 4, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
387 later devices descend from it, 18 citing it directly.
- This deviceK051971 Optima Spinal SystemU&I Corp. · 2005
- Descendant · cites it directly · 179 of its ownK062513 Apex Spine SystemSpinecraft, Inc. · 2006
- Descendant · 2 generations on · 178 of its ownK092825 Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010
- Descendant · 2 generations on · 177 of its ownK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- Descendant · 2 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
Showing 5 of 387 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 387 · See all- K062513Apex Spine SystemSpinecraft, Inc. · 2006 · cites it directly179descendants
- K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010 · 2 generations on178descendants
- K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010 · 2 generations on177descendants
- K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · 2 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051971 | Optima Spinal System | U&I Corp. | 2005 | — |
| +1 | K062513 | Apex Spine System | Spinecraft, Inc. | 2006 | — |
| +2 | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer | Spinecraft, Inc. | 2010 | — |
| +2 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| +1 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| +2 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 15 | 0 |
| 2015 | 23 | 0 |
| 2016 | 16 | 0 |
| 2017 | 18 | 0 |
| 2018 | 28 | 0 |
| 2019 | 18 | 0 |
| 2020 | 29 | 0 |
| 2021 | 20 | 0 |
| 2022 | 30 | 0 |
| 2023 | 40 | 0 |
| 2024 | 37 | 0 |
| 2025 | 38 | 0 |
| 2026 | 34 | 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (387)
See all 38718 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062513 | Apex Spine System | 2006 | 179 |
| K120291 | OP Spine System | 2012 | 138 |
| K103085 | Venus Basic Spinal Fixation System | 2011 | 123 |
| K101278 | Inertia Pedicle Screw System | 2010 | 111 |
| K102853 | Flamenco Spinal Fixation System | 2011 | 22 |
| K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | 2015 | 5 |
| K151704 | Diplomat® Spinal System | 2016 | 4 |
| K161516 | G Surgical Marksman MIS System | 2016 | 3 |
| K111883 | Smartloc Spinal Fixation System | 2011 | 2 |
| K192930 | Dymaxeon Spine System | 2020 | 1 |
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, K062513 (Spinecraft, Inc., 2006) has gone furthest, with 179 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The OPTIMATM posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the OPTIMATM is intended to provide immobilization and…
Read the full statement (189 words)
The OPTIMATM posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMATM is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPTIMATM 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 such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMATM may be used with posterior hook.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051971: Optima 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/K051971
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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