510(k) · Cleared
ClearedBlackbird Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 7, 2014 as substantially equivalent to K050979 (Aesculap, Inc., 2005) and 3 other predicates after a 140-day review. Its family tree reaches back 9 generations to 1985. 3 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 140 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K853033 (1985). 23 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- This deviceK133214 Blackbird Spinal SystemChoicespine, LP · 2014
- Descendant · cites it directly · 1 of its ownK203561 ChoiceSpine Navigation SystemChoice Spine, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK220024 ChoiceSpine Navigation SystemChoice Spine, LLC · 2022
- Descendant · cites it directly · 0 of its ownK220025 ARx® Spinal SystemLife Spine, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- This deviceK133214 Blackbird Spinal SystemChoicespine, LP · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| 0 (this device) | K133214 | Blackbird Spinal System | Choicespine, LP | 2014 | — |
| +1 | K203561 | ChoiceSpine Navigation System | Choice Spine, LLC | 2021 | — |
| +2 | K220024 | ChoiceSpine Navigation System | Choice Spine, LLC | 2022 | — |
| +1 | K220025 | ARx® Spinal System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K050979 | S4 Spinal SystemSummary page 2…Page 2 of 2 Predicate Device(s): The BLACKBIRD TM Spinal System is substantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Sy… | 2005 |
| * | K070638 | Theken Atoll Cervico-Thoracic SystemSummary page 2…age 2 of 2 Predicate Device(s): The BLACKBIRD TM Spinal System is substantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems. Performance Standards: Performanc… | 2007 |
| * | K052201 | Solanas Posterior Stabilization SystemSummary page 2…tem is substantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems. Performance Standards: Performance testing was completed by an independent laboratory followin… | 2005 |
| * | K071380 | Modification to Solanas Posterior Stabilization SystemSummary page 2…bstantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems. Performance Standards: Performance testing was completed by an independent laboratory following ASTM F1… | 2007 |
What descends from it? (3)
2 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?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K203561 (Choice Spine, LLC, 2021) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K050979.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The BLACKBIRD h Spinal System is Intended to be used In skeletally mature patents as an adjunct to fusion for stabilization of the cervical spine & thoracic spine (C1-T3) for the following conditions: * degenerative disc disease (ODD; defined as neck pain of discogenic origin with degeneration of the disk as confirmed by history & radiographic studies) * spondylolistiiesls " trauma " fracture / dislocation * spinal stenosis * atianto/axial fracture with…
Read the full statement (143 words)
The BLACKBIRD h Spinal System is Intended to be used In skeletally mature patents as an adjunct to fusion for stabilization of the cervical spine & thoracic spine (C1-T3) for the following conditions:
* degenerative disc disease (ODD; defined as neck pain of discogenic origin with degeneration of the disk as confirmed by history & radiographic studies)
* spondylolistiiesls
" trauma
" fracture / dislocation
* spinal stenosis
* atianto/axial fracture with instability
* tumor
* revision of previous cervical spine surgery
The use of polyaxial screws Is limited to placement Inthe thoracic spine (TI-Tl) "for anchoring the construct only" and Is not Intended to be placed Inthe cervical spine. The use of the rods and hook components are Intended for use In(Cl -T). This system can be linked to a 06.0mmn rod system such as the Choice Spine Starfirem Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133214: Blackbird Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133214
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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