510(k) · Cleared
ClearedSpinal Concepts, Inc. Bacfix TI Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 17, 2003 as substantially equivalent to K013887 (Spinal Concepts, Inc., 2002) and 7 other predicates after a 189-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 17, 2003
- Review
- 189 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K980447 (1998). 14 ancestors in all, the oldest K953925 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 2 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 1 generation backK022605 Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002
- This deviceK030087 Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −2 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −1 | K022605 | Blackstone Spinal Fixation System Staple & Washer | Blackstone Medical, Inc. | 2002 | — |
| 0 (this device) | K030087 | Spinal Concepts, Inc. Bacfix TI Spinal System | Spinal Concepts, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 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? (8)
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 |
|---|---|---|---|
| * | K013887 | Bacfix Spinal Fixation System | 2002 |
| * | K021564 | Incompass Spinal Fixation System | 2002 |
| * | K023644 | Modification to Incompass Spinal Fixation SystemSummary page 1…887). - Spinal Concepts, Inc. Incompass Spinal Fixation System (KO21564 and K023644). - BlackstoneTMSpinal Fixation System Staple & Washer - System… | 2002 |
| * | K022605 | Blackstone Spinal Fixation System Staple & WasherSummary page 1…4). - BlackstoneTMSpinal Fixation System Staple & Washer - System Addition (K022605). - DePuy-Acromed Moss Miami (K953925) -… | 2002 |
| * | K953925 | Fine Grain Cast Cobalt Chromium Hip StemsSummary page 1…em Staple & Washer - System Addition (K022605). - DePuy-Acromed Moss Miami (K953925) - Synthes USS (K000450) - Medtronic… | 1996 |
| * | K000450 | Modification to Synthes UssSummary page 1…Addition (K022605). - DePuy-Acromed Moss Miami (K953925) - Synthes USS (K000450) - Medtronic Sofamor Danek CD Horizon (K001066)… | 2000 |
| * | K001066 | CD Horizon EclipseSummary page 1…Miami (K953925) - Synthes USS (K000450) - Medtronic Sofamor Danek CD Horizon (K001066) - Medtronic Sofamor Danek TSRH (K982990) DEVICE DESCRIPTION The purpose… | 2000 |
| * | K982990 | TSRH Spinal SystemSummary page 1…- Medtronic Sofamor Danek CD Horizon (K001066) - Medtronic Sofamor Danek TSRH (K982990) DEVICE DESCRIPTION The purpose of this abbreviated 5 1O(k) Notification is to add Staple, Nut and Washer components to… | 1998 |
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 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K013887.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When intended for pedicle screw fixation, implants are 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative…
Read the full statement (315 words)
When intended for pedicle screw fixation, implants are 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.
When intended for anterolateral screw, rod and or cable fixation of the T6L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (Le. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for these indications range from L3 to the sacrum.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are:
Idiopathic scoliosis.
Neuromuscular scoliosiskyphoscoliosis with associated paralysis or spasticity.
Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
Spinal fractures (acute reduction or late deformity).
Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Neoplastic disease.
Spondylolisthesis.
Spinal Stenosis.
Failed previous fusion.
The cable-screws, cables and spinous process grommets are indicated for:
Defect of pars lateralis.
Spondylolisthesis.
Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030087: Spinal Concepts, Inc. Bacfix TI Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030087
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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