510(k) · Cleared
ClearedJ.B. S. C1-C2 Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.B.S., S.A. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 15, 1996 as substantially equivalent to K945022 (Sofamor Co., 1995) after a 79-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 15, 1996
- Review
- 79 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945022 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945022 Apofix Cervical Spine FixationSofamor Co. · 1995
- This deviceK955864 J.B. S. C1-C2 ClampJ.B.S., S.A. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945022 | Apofix Cervical Spine Fixation | Sofamor Co. | 1995 | — |
| 0 (this device) | K955864 | J.B. S. C1-C2 Clamp | J.B.S., S.A. | 1996 | — |
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? (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 |
|---|---|---|---|
| * | K945022 | Apofix Cervical Spine FixationSummary page 1…ch inhibits the potential of bony fusion (i.e., osteoporosis, kidney dialysis, etc.). Substantially Equivalent Devices: 1. The APOFIX fixation device by Sofamor Danek (K945022) 2. The HALIFAX clamp Distributed by Aesculap Aesculap Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Made in France by J.… | 1995 |
| * | — | HALIFAX clamp Named without a submission number |
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?
- Its one ancestor has no recall.
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?
Fixation of C1-C2 in case of fracture or multi-operated back.
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/K955864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955864: J.B. S. C1-C2 Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955864
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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