510(k) · Cleared
ClearedBryan Posterior Spinal Fixator (BPSF), Modified
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arcan Orthopaedic Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 16, 1997 after a 110-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 16, 1997
- Review
- 110 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971457 Bryan Posterior Spinal Fixator (BPSF), ModifiedArcan Orthopaedic Corp. · 1997
- Descendant · cites it directly · 0 of its ownK053070 Contour II Spinal SystemAltiva Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053070Contour II Spinal SystemAltiva Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971457 | Bryan Posterior Spinal Fixator (BPSF), Modified | Arcan Orthopaedic Corp. | 1997 | — |
| +1 | K053070 | Contour II Spinal System | Altiva Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (5)
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 |
|---|---|---|---|
| * | — | Harrington rod Named without a submission number | |
| * | — | Harrington hook Named without a submission number | |
| * | — | Harrington sacral screw Named without a submission number | |
| * | — | Harrington lag screw inserted into the pedicle of L5 Named without a submission number | |
| * | — | Dwyer anterior vertebral screw 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 |
|---|---|---|---|
| K053070 | Contour II Spinal System | 2006 | 0 |
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, K053070 (Altiva Corp., 2006) has gone furthest, with 0 descendants of its own.
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?
When used as a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the indications for use are: - spondylolisthesis - fracture - spinal stenosis - deformities(scoliosis, kyphosis, lordosis) - pseudarthrosis - tumor - multi-operated back or revision of previous surgery The system is indicated for pedicle screw fixation (MINH) L3-S1, ilium as follows: When used as a pedicle screw fixation system the device system is intended for patients: (a)…
Read the full statement (122 words)
When used as a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the indications for use are:
- spondylolisthesis
- fracture
- spinal stenosis
- deformities(scoliosis, kyphosis, lordosis)
- pseudarthrosis
- tumor
- multi-operated back or revision of previous surgery
The system is indicated for pedicle screw fixation (MINH) L3-S1, ilium as follows:
When used as a pedicle screw fixation system the device system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
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/K971457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971457: Bryan Posterior Spinal Fixator (BPSF), Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971457
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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