510(k) · Cleared
ClearedLanx Posterior Cervicothoracic Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 24, 2009 as substantially equivalent to K071905 (Lanx, LLC, 2007) and 2 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1985. 5 later devices descend from it.
- Decided
- Nov 24, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K853033 (1985). 27 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
- This deviceK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK100888 Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK100191 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK103040 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2011
- Descendant · cites it directly · 1 of its ownK113434 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK140734 Nextgen Altius Oct SystemEbi, LLC · 2014
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
- This deviceK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2010 · cites it directly3descendants
- K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2010 · cites it directly3descendants
- K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2011 · cites it directly2descendants
- K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2011 · cites it directly1descendant
- K140734Nextgen Altius Oct SystemEbi, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, LLC | 2007 | — |
| 0 (this device) | K092656 | Lanx Posterior Cervicothoracic Spinal Fixation System | Lanx, Inc. | 2009 | — |
| +1 | K100888 | Modification to Lanx Posterior Cervicothoracic Spinal Fixation System | Lanx, Inc. | 2010 | — |
| +1 | K100191 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, Inc. | 2010 | — |
| +1 | K103040 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, LLC | 2011 | — |
| +1 | K113434 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, Inc. | 2011 | — |
| +2 | K140734 | Nextgen Altius Oct System | Ebi, LLC | 2014 | — |
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 | 5 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS)Summary page 1…MN] - 21 CFR 888.3070 - Pedicle Screw Spinal System KWP -21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis Predicate Device Information K071905 Lanx PCFS Lanx, Inc. K030197 Ascent PCS Blackstone Medical, Inc. K042508… | 2007 |
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…KWP -21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis Predicate Device Information K071905 Lanx PCFS Lanx, Inc. K030197 Ascent PCS Blackstone Medical, Inc. K042508 Summit/Mountaineer OCT Depuy Spine, Inc. Int… | 2003 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 1…tion Orthosis Predicate Device Information K071905 Lanx PCFS Lanx, Inc. K030197 Ascent PCS Blackstone Medical, Inc. K042508 Summit/Mountaineer OCT Depuy Spine, Inc. Intended Use / Indications for Use When intended to promote fusion of the… | 2004 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100888 | Modification to Lanx Posterior Cervicothoracic Spinal Fixation System | 2010 | 3 |
| K100191 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2010 | 3 |
| K103040 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2011 | 2 |
| K113434 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2011 | 1 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K100888 (Lanx, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K071905.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following: * Degenerative Disc Disease (as defined by neck and back pain o.f discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Trauma/Fracture/Dislocation ·…
Read the full statement (119 words)
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
* Degenerative Disc Disease (as defined by neck and back pain o.f discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
* Spondylolisthesis
* Spinal Stenosis
* Trauma/Fracture/Dislocation
· Atlanto-Axial Fracture with Instability
* Occipito-Cervical Dislocation
* Failed Previous Fusion
• Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use ofpolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092656: Lanx Posterior Cervicothoracic Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092656
Report an extraction error
Are you the manufacturer?
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