510(k) · Cleared
ClearedDynamo™ Spinal Cement; Salvo® Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Jun 15, 2026 as substantially equivalent to K241034 (Medacta International S.A., 2024) and 1 other predicate after a 137-day review. Its family tree reaches back 22 generations to 1985. 1 of the 294 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 15, 2026
- Review
- 137 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K853033 (1985). 293 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 294 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations between
- 3 generations backK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- 2 generations backK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
- 1 generation backK240685 Salvo® Spine SystemSpine Wave, Inc. · 2024
- This deviceK260286 Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
Show all 22 generations
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 21 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 20 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 19 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 18 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 17 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 16 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 15 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 14 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 13 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 12 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 11 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 10 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 9 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 8 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 7 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 6 generations backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- 5 generations backK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- 4 generations backK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- 3 generations backK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- 2 generations backK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
- 1 generation backK240685 Salvo® Spine SystemSpine Wave, Inc. · 2024
- This deviceK260286 Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −21 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −20 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −19 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −18 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −17 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −16 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −15 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −14 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −13 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −12 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −11 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −10 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −9 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −8 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −7 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| −6 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| −5 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| −4 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| −3 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| −2 | K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022 | — |
| −1 | K240685 | Salvo® Spine System | Spine Wave, Inc. | 2024 | — |
| 0 (this device) | K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 12 | 0 |
| 2003 | 16 | 0 |
| 2004 | 28 | 0 |
| 2005 | 23 | 0 |
| 2006 | 14 | 0 |
| 2007 | 14 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 11 | 1 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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.
Top candidate predicates for a new PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemSummary page 5…Code Meta+ Bone Cement & M.U.S.T. Fenestrated PML, K241034 Medacta Pedicle Screw System… | 2024 |
| * | K240685 | Salvo® Spine SystemSummary page 5…510(k) Trade Name Manufacturer Code K240685 Salvo® Spine System Spine Wave NKB 4. Device Description Summary The Salvo® Spine S… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 35 of the 293 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K241034.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used in a percutaneous…
Read the full statement (316 words)
The Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, the Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When the Salvo® Spine System fenestrated screws are used in conjunction with Dynamo TM Spinal Cements (MV or HV), the Salvo® Spine System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Salvo® fenestrated screws augmented with the Dynamo TM Spinal Cements (MV or HV) are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Dynamo TM Spinal Cements (MV or HV), when used in conjunction with the Salvo® Spine System fenestrated screws, are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. Dynamo TM Spinal Cements (MV or HV) are limited for use at spinal levels where the structural integrity of the spine is not severely compromised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260286: Dynamo™ Spinal Cement; Salvo® Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260286
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026