510(k) · Cleared
ClearedLanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
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 Apr 15, 2010 as substantially equivalent to K092656 (Lanx, Inc., 2009) and 1 other predicate after an 83-day review. Its family tree reaches back 11 generations to 1985. 3 later devices descend from it.
- Decided
- Apr 15, 2010
- Review
- 83 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K853033 (1985). 28 ancestors in all. 3 later devices descend from it, 2 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 backK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
- 1 generation backK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
- This deviceK100191 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 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 backK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
- 1 generation backK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
- This deviceK100191 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- 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 |
|---|---|---|---|---|---|
| −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 | K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, LLC | 2007 | — |
| −1 | K092656 | Lanx Posterior Cervicothoracic Spinal Fixation System | Lanx, Inc. | 2009 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K092656 | Lanx Posterior Cervicothoracic Spinal Fixation SystemSummary page 1…me: Spinal Fixation System Classification: KWP - 21 CFR 888.3050 - Spinal Interlarninal Fixation Orthosis Predicate Device Information K092656 Lanx PCFS Lanx, Inc. K052201 Solanas Aiphatec Spine, Inc. Intended Use!/ Indications… | 2009 |
| * | K052201 | Solanas Posterior Stabilization SystemSummary page 1…sification: KWP - 21 CFR 888.3050 - Spinal Interlarninal Fixation Orthosis Predicate Device Information K092656 Lanx PCFS Lanx, Inc. K052201 Solanas Aiphatec Spine, Inc. Intended Use!/ Indications for Use When intended to promote fusion of the oc… | 2005 |
What descends from it? (3)
2 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 25 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K103040 (Lanx, LLC, 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K092656.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 of discogenic origin with degeneration of the disc confirmed by history and radiographic Studies) * Spondylolisthesis * Spinal Stenosis * Traumatic Fracture/Dislocation *…
Read the full statement (121 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 of discogenic origin with degeneration of the disc confirmed by history and radiographic Studies)
* Spondylolisthesis
* Spinal Stenosis
* Traumatic 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 of polyaxial 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/K100191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100191: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100191
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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