510(k) · Cleared
ClearedTechtonix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 16, 2005 as substantially equivalent to K991055 (Howmedica Osteonics Corp., 1999) after a 20-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Feb 16, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991055 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991055 Osteonics Spinal System- Rod/ Plate SystemHowmedica Osteonics Corp. · 1999
- This deviceK050189 Techtonix SystemStryker Spine · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991055 | Osteonics Spinal System- Rod/ Plate System | Howmedica Osteonics Corp. | 1999 | — |
| 0 (this device) | K050189 | Techtonix System | Stryker Spine | 2005 | — |
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 KWP? 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 |
|---|---|---|---|
| * | K991055 | Osteonics Spinal System- Rod/ Plate SystemSummary page 1…System are substantially equivalent to the features of the Osteonics®r Spinal System Rod! Plate System (RPS) which was determnined substantially equivalent via 510(k) K991055. Description of Device Modification This submission is intended to expand the Osteonics®'Spinal System Rod! Plate System pro… | 1999 |
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.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix T System are indicated for: • Long and short curve scoliosis • Vertebral fracture or dislocation • Spondylolisthesis • Degenerative disc disease (defined as back pain of discogneic origin with degeneration of the disc confirmed by history and radiographic studies) • Previously failed fusion • Spinal tumor Pedicular Use: • When used as…
Read the full statement (194 words)
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix T System are indicated for:
• Long and short curve scoliosis
• Vertebral fracture or dislocation
• Spondylolisthesis
• Degenerative disc disease (defined as back pain of discogneic 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 Rod/Plate System and Techtonix TM System are 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 (pseudoarthrosis).
• In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix System are indicated for pedicde 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 as stated in the FDA summary.
https://510kreport.com/device/K050189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050189: Techtonix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050189
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