510(k) · Cleared
Recalled · 2002Modification to Spinal Concepts Bacfix TI Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 21, 1998 after a 35-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 21, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983260 Modification to Spinal Concepts Bacfix TI Spinal Fixation SystemSpinal Concepts, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK132575 Pass LP Spinal SystemMedicrea International · 2013
Most influential descendants
Showing 1 of 1 · See all- K132575Pass LP Spinal SystemMedicrea International · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983260 | Modification to Spinal Concepts Bacfix TI Spinal Fixation System | Spinal Concepts, Inc. | 1998 | — |
| +1 | K132575 | Pass LP Spinal System | Medicrea International | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 MNI? 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? (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 |
|---|---|---|---|
| * | — | BacFix™ Spinal Fixation System Named without a submission number | |
| * | — | Synthes Universal Spinal System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132575 | Pass LP Spinal System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2002 | Not classified | Z-0921-04 | Other | The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132575 (Medicrea International, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-S1). 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…
Read the full statement (259 words)
The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-S1).
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 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.
In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of 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:
1. Idiopathic scoliosis.
2. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Spinal fractures (acute reduction or late deformity).
5. 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983260: Modification to Spinal Concepts Bacfix TI Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983260
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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