510(k) · Cleared
ClearedRansford Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 7, 1997 as substantially equivalent to K853033 (A.W. Showell (Surgicraft), Ltd., 1985) after a 219-day review. Its family tree reaches back 1 generation to 1985. 2 of the 696 devices in its family, counting itself, have a Class I recall. 694 later devices descend from it.
- Decided
- Aug 7, 1997
- Review
- 219 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853033 (1985). 694 later devices descend from it, 3 citing it directly. 2 of the 696 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- This deviceK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- Descendant · cites it directly · 692 of its ownK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- Descendant · cites it directly · 671 of its ownK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- Descendant · 2 generations on · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- Descendant · 2 generations on · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- Descendant · 2 generations on · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
Showing 5 of 694 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 694 · See all- K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998 · cites it directly692descendants
- K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000 · cites it directly671descendants
- K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · 2 generations on660descendants
- K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · 2 generations on659descendants
- K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · 2 generations on658descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| 0 (this device) | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| +1 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| +1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| +2 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| +2 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| +2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 10 | 0 |
| 2008 | 15 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 1 |
| 2011 | 16 | 0 |
| 2012 | 29 | 0 |
| 2013 | 32 | 0 |
| 2014 | 32 | 0 |
| 2015 | 38 | 0 |
| 2016 | 29 | 0 |
| 2017 | 38 | 0 |
| 2018 | 39 | 0 |
| 2019 | 32 | 0 |
| 2020 | 39 | 0 |
| 2021 | 33 | 1 |
| 2022 | 38 | 0 |
| 2023 | 67 | 0 |
| 2024 | 57 | 0 |
| 2025 | 52 | 0 |
| 2026 | 50 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K853033 | Hartshill Rect & Wires, Spinal Fixation SystemSummary page 3…8. Substantially Equivalent Device(s): The RANSFORD CERVICAL FIXATION SYSTEM ™ is substantially equivalent to the following device: 1. Hartshill Spinal Fixation System - K853033 9. Comparison to Predicate Device(s): Surgicraft, Ltd. currently manufactures a legally marketed device for the same indication… | 1985 |
What descends from it? (694)
See all 6943 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
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?
1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis of the cervical vertebrae
Spinal stenosis of the cervical vertebrae
Atlanto/axial fracture with instability
Cervical-occipital dislocation
Revision of previous cervical spine surgery
Tumors
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/K965221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965221: Ransford Cervical 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/K965221
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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