510(k) · Cleared
ClearedButterfly Plate Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 25, 2002 as substantially equivalent to K010632 (Medtronic Sofamor Danek USA, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1993. 1 of the 281 devices in its family, counting itself, has a Class I recall. 278 later devices descend from it.
- Decided
- Jan 25, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922543 (1993). 2 ancestors in all. 278 later devices descend from it, 1 citing it directly. 1 of the 281 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- This deviceK014267 Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 277 of its ownK022070 Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · 2 generations on · 276 of its ownK071416 Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007
- Descendant · 3 generations on · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 3 generations on · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 4 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
Showing 5 of 278 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 278 · See all- K022070Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002 · cites it directly277descendants
- K071416Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007 · 2 generations on276descendants
- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on228descendants
- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on190descendants
- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 4 generations on155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| 0 (this device) | K014267 | Butterfly Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K022070 | Xantus Anterior Lateral Supplemental Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +2 | K071416 | Pyramid +4 Anterior Lumbar Spine Plate System | Medtronic Sofamor Danek USA, Inc. | 2007 | — |
| +3 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +3 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +4 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 15 | 0 |
| 2020 | 16 | 0 |
| 2021 | 23 | 1 |
| 2022 | 30 | 0 |
| 2023 | 35 | 0 |
| 2024 | 53 | 0 |
| 2025 | 41 | 0 |
| 2026 | 42 | 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? (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 |
|---|---|---|---|
| * | K010632 | Butterfly Plate Function SystemSummary page 1…al Body Fixation Orthosis, Class II The BUTTERFLY PLATE Fixation System is substantially equivalent to itself, the BUTTERFLY PLATE Fixation System, which was cleared in K010632 on May 31, 2001 and the Sofamor Danek Z-Plate Anterior Fixation System, which was cleared on May 19, 1993. The BUTTERFLY PLATE F… | 2001 |
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 2…ned in this submission are substantially equivalent to the original BUTTERFLY PLATE Fixation System (K010632) and to the Sofamor Danek Z-Plate Anterior Fixation System (K922543). paqe SPRT=N T T Uou ol e"'mq"’*- @ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service &, nuur,,‘… | 1993 |
What descends from it? (278)
See all 2781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022070 | Xantus Anterior Lateral Supplemental Fixation System | 2002 | 277 |
Has anything in its family been recalled? (1 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
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?
The BUTTERFLY™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1. Degenerative…
Read the full statement (179 words)
The BUTTERFLY™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.
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/K014267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014267: Butterfly Plate Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014267
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026