510(k) · Cleared
ClearedBacfix Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 12, 2002 after an 81-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK013887 Bacfix Spinal Fixation SystemSpinal Concepts, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK031354 Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2003
- Descendant · 2 generations on · 11 of its ownK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 11 of its ownK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
- Descendant · 3 generations on · 10 of its ownK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · 3 generations on · 9 of its ownK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031354Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2003 · cites it directly13descendants
- K082353Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 2 generations on11descendants
- K083230Mercury Spinal SystemSpinal Elements, Inc. · 2008 · 2 generations on11descendants
- K091587Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 3 generations on10descendants
- K141372Mercury Spinal SystemSpinal Elements, Inc. · 2014 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013887 | Bacfix Spinal Fixation System | Spinal Concepts, Inc. | 2002 | — |
| +1 | K031354 | Ebi OMEGA21 Spinal Fixation System | Ebi, L.P. | 2003 | — |
| +2 | K082353 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +2 | K083230 | Mercury Spinal System | Spinal Elements, Inc. | 2008 | — |
| +3 | K091587 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +3 | K141372 | Mercury Spinal System | Spinal Elements, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 MNH? 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 |
|---|---|---|---|
| * | — | Isola Spinal System Named without a submission number |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031354 (Ebi, L.P., 2003) has gone furthest, with 13 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1). When intended for pedicle screw fixation, implants are intended to provide immobilization and stabilization of spinal segments in skeletally…
Read the full statement (303 words)
The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to 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 or 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range to T1 to the sacrum.
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 this indication are from L3 to the sacrum.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are:
Idiopathic scoliosis.
Neuromuscular scoliosis/kyphoscoliosis 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013887: Bacfix Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013887
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026