510(k) · Cleared
Recalled · 2010Blackstone Posterior Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 12, 2003 as substantially equivalent to K002733 (Depuyacromed, 2000) after a 142-day review. Its family tree reaches back 4 generations to 1985. 1 of the 203 devices in its family, counting itself, has a Class I recall. 193 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 2003
- Review
- 142 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853033 (1985). 9 ancestors in all. 193 later devices descend from it, 12 citing it directly. 1 of the 203 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- This deviceK030197 Blackstone Posterior Cervical SystemBlackstone Medical, Inc. · 2003
- Descendant · cites it directly · 139 of its ownK042100 Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc. · 2004
- Descendant · cites it directly · 134 of its ownK033980 Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc. · 2004
- Descendant · cites it directly · 129 of its ownK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 124 of its ownK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
- Descendant · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
Showing 5 of 193 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 193 · See all- K042100Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc. · 2004 · cites it directly139descendants
- K033980Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc. · 2004 · cites it directly134descendants
- K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008 · cites it directly129descendants
- K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008 · cites it directly124descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 2 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| 0 (this device) | K030197 | Blackstone Posterior Cervical System | Blackstone Medical, Inc. | 2003 | — |
| +1 | K042100 | Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector | Blackstone Medical, Inc. | 2004 | — |
| +1 | K033980 | Blackstone Ascent Poct System Hooks (System Modification) | Blackstone Medical, Inc. | 2004 | — |
| +1 | K073654 | Blackstone Ascent Poct System Parallel Rod Connector | Blackstone Medical, Inc. | 2008 | — |
| +1 | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | Blackstone Medical, Inc. | 2008 | — |
| +2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 1 |
| 2022 | 11 | 0 |
| 2023 | 19 | 0 |
| 2024 | 25 | 0 |
| 2025 | 19 | 0 |
| 2026 | 22 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…KWP - 888.3050 - Spinal Lnterlaminal Fixation Orthosis Substantially Equivalent Devices: DePuy AcroMedTM,Summit (OTC) Spinal System (K002733) Device Description: The BlackstoneTMPosterior Cervical System is a titanium alloy, multiple component system comprised of a va… | 2000 |
What descends from it? (193)
See all 19312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042100 | Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector | 2004 | 139 |
| K033980 | Blackstone Ascent Poct System Hooks (System Modification) | 2004 | 134 |
| K073654 | Blackstone Ascent Poct System Parallel Rod Connector | 2008 | 129 |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | 2008 | 124 |
| K101084 | Caspian Spinal System | 2010 | 62 |
| K111183 | Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods) | 2011 | 22 |
| K073420 | Blackstone Ascent Multiaxial Screws | 2008 | 9 |
| K171369 | M.U.S.T. MINI Posterior Cervical Screws System | 2017 | 8 |
| K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2007 | 6 |
| K092656 | Lanx Posterior Cervicothoracic Spinal Fixation System | 2009 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2010 | Not classified | Z-1144-2010 | Labeling mix-ups | The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium. |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K042100 (Blackstone Medical, Inc., 2004) has gone furthest, with 139 descendants of its own.
- 15 other devices also cite its predicate K002733.
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 intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the BlackstoneTM Posterior Cervical System is indicated for: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) b) spondylolisthesis c) spinal stenosis d) fracture/dislocation e) atlantoaxial fracture with instability f) occipito-cervical dislocation g)…
Read the full statement (131 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the BlackstoneTM Posterior Cervical System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
f) occipito-cervical dislocation
g) revision of previous cervical spine surgery
h) tumors
The occipital bone screws are limited to occipital fixation only.
The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System to be used with the BlackstoneTM Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030197: Blackstone Posterior Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030197
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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