510(k) · Cleared
ClearedDepuy Pulse Thoracolumbar Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 8, 2012 as substantially equivalent to K953915 (Depuy, Inc., 1996) and 8 other predicates after a 93-day review. Its family tree reaches back 12 generations to 1985. 1 later device descends from it.
- Decided
- Feb 8, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 12 generations to K853033 (1985). 46 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK113396 Depuy Pulse Thoracolumbar Screw SystemMedos International SARL · 2012
- Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK113396 Depuy Pulse Thoracolumbar Screw SystemMedos International SARL · 2012
Most influential descendants
Showing 1 of 1 · See all- K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K113396 | Depuy Pulse Thoracolumbar Screw System | Medos International SARL | 2012 | — |
| +1 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM… | Medos International SARL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
Planning a device in NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K953915 | Moss Miami Spinal System (Anterior Use)Summary page 1…ody Fixation Orthosis Pedicle Screw Spinal System Regulation Number: 888.3050, 888.3060, 888.3070 Predicate Devices: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081… | 1996 |
| * | K033901 | Merlin Spine SystemSummary page 1…cle Screw Spinal System Regulation Number: 888.3050, 888.3060, 888.3070 Predicate Devices: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081898, K(103490 Device Description: The DePuy… | 2004 |
| * | K051024 | Expedium Spine System | 2005 |
| * | K062174 | Modification to Expedium Spine System | 2006 |
| * | K063156 | Modification to Expedium Spine System | 2006 |
| * | K063741 | Expedium Spine SystemSummary page 1…888.3050, 888.3060, 888.3070 Predicate Devices: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081898, K(103490 Device Description: The DePuy Pulse Thoracolumbar Screw System consists o… | 2007 |
| * | K080313 | Modification to Expedium Spine SystemSummary page 1…Predicate Devices: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081898, K(103490 Device Description: The DePuy Pulse Thoracolumbar Screw System consists of a variety of… | 2008 |
| * | K081898 | Expedium Spine SystemSummary page 1…ate Devices: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081898, K(103490 Device Description: The DePuy Pulse Thoracolumbar Screw System consists of a variety of rod… | 2008 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 1…: Moss Miami System - K953915 Expedium System - K033901, K(05 1024, K(062 174, K(063 156, 1K063741 K(080313,1K081898, K(103490 Device Description: The DePuy Pulse Thoracolumbar Screw System consists of a variety of rods, pedicle… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 46 ancestors has a recall.
- Of its descendants, K191212 (Medos International SARL, 2019) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K953915.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The DePoy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications…
Read the full statement (110 words)
The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The DePoy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113396: Depuy Pulse Thoracolumbar Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113396
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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