510(k) · Cleared
ClearedTI-Tamed Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ti-Tamed (Pty), Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 31, 2009 as substantially equivalent to K022623 (Depuyacromed, 2002) and 1 other predicate after a 903-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jul 31, 2009
- Review
- 903 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955348 (1996). 11 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 3 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 2 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- 1 generation backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- This deviceK070385 TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −3 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −2 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| −1 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| 0 (this device) | K070385 | TI-Tamed Spinal System | Ti-Tamed (Pty), Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 1…fixation Device System, Pedicle Screw Fixation System. Equivalent device: Moss Miami Spinal System - DePuy Acromed, Inc. K022623 Polaris 5.5 - Bioimet Spine. K081952 Product Description: The Ti-TaMED Spinal System… | 2002 |
| * | K081952 | Synergy Spinal System (6.35 Polaris) Cleared while this submission was under review Summary page 1…em. Equivalent device: Moss Miami Spinal System - DePuy Acromed, Inc. K022623 Polaris 5.5 - Bioimet Spine. K081952 Product Description: The Ti-TaMED Spinal System consists of a variety of rods, hooks, screws, cross connectors and other co… | 2008 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 28 other devices also cite its predicate K022623.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain…
Read the full statement (109 words)
The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070385: TI-Tamed 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/K070385
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