510(k) · Cleared
ClearedAscent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 24, 2011 as substantially equivalent to K030197 (Blackstone Medical, Inc., 2003) and 2 other predicates after a 27-day review. Its family tree reaches back 11 generations to 1985. 22 later devices descend from it.
- Decided
- May 24, 2011
- Review
- 27 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K853033 (1985). 80 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- 1 generation backK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
- This deviceK111183 Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt…Orthofix, Inc. · 2011
- Descendant · cites it directly · 18 of its ownK170647 Connector SystemOrthofix, Inc. · 2017
- Descendant · 2 generations on · 16 of its ownK172194 Connector SystemOrthofix, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 3 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- Descendant · 4 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- 1 generation backK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
- This deviceK111183 Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt…Orthofix, Inc. · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K170647Connector SystemOrthofix, Inc. · 2017 · cites it directly18descendants
- K172194Connector SystemOrthofix, Inc. · 2017 · 2 generations on16descendants
- K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on8descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 3 generations on7descendants
- K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K111183 | Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome… | Orthofix, Inc. | 2011 | — |
| +1 | K170647 | Connector System | Orthofix, Inc. | 2017 | — |
| +2 | K172194 | Connector System | Orthofix, Inc. | 2017 | 2 |
| +2 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | — |
| +3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| +4 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…50 - Spinal Interlaminal Fixation Orthosis Review Panel: Orthopedic Device Panel Predicate Devices: Blackstone Posterior Cervical System, K030197, SE 6-12-03 Ascent POCT System, K080394, SE 3-13-08 (Plate and Rod… | 2003 |
| * | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemSummary page 1…Orthopedic Device Panel Predicate Devices: Blackstone Posterior Cervical System, K030197, SE 6-12-03 Ascent POCT System, K080394, SE 3-13-08 (Plate and Rod Modifications) Firebird Spinal Fixation… | 2008 |
| * | K092624 | Firebird Spinal Fixation SystemSummary page 1…and Rod Modifications) Firebird Spinal Fixation System, Cobalt Chrome Rods, K092624, SE 9-25-2009 Reason for 51 0(k) Submission: New product offering Orthofix inc., 3451 Plano Parkway, Lewisville… | 2009 |
What descends from it? (22)
See all 223 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 26 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 80 ancestors have a recall of any class.
- Of its descendants, K170647 (Orthofix, Inc., 2017) has gone furthest, with 18 descendants of its own.
- 11 other devices also cite its predicate K030197.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for: a. degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); b. spondylolisthesis; c. fracture/dislocation; d. spinal stenosis; e. atlanto-axial fracture with instability; f. occipito-cervical dislocation; g.…
Read the full statement (186 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:
a. degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b. spondylolisthesis;
c. fracture/dislocation;
d. spinal stenosis;
e. atlanto-axial fracture with instability;
f. occipito-cervical dislocation;
g. tumors;
h. revision of previous cervical spine surgery
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) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.
The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111183: Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111183
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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