510(k) Report

510(k) · Cleared

Cleared

Posterior Cervicothoracic Spinal Fixation System (PCFS)

K071905510(k) TraditionalCleared Dec 28, 2007171-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lanx, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 28, 2007 as substantially equivalent to K052317 (Stryker Spine, 2005) and 9 other predicates after a 171-day review. Its family tree reaches back 9 generations to 1985. 6 later devices descend from it.

Decided
Dec 28, 2007
Review
171 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
10

Its longest line of descent runs back 9 generations to K853033 (1985). 26 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 3 other ancestors2004: 5 other ancestors2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1999: 4 other ancestors2000: 1 other ancestor2011: 2 descendants cleared2014: 1 descendant cleared2009: 1 descendant cleared2010: 2 descendants clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003×2: 2 generations cleared close together, K041203 (2004), K042508 (2004) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 4 other ancestors3 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K042508 · Sumit Oct Spinal System and Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2004K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−50
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 5 generations between
  3. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  4. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  5. 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  6. This deviceK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
  7. Descendant · cites it directly · 5 of its ownK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
  8. Descendant · 2 generations on · 3 of its ownK100888 Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2010
  9. Descendant · 2 generations on · 3 of its ownK100191 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2010
  10. Descendant · cites it directly · 2 of its ownK103040 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2011
  11. Descendant · cites it directly · 1 of its ownK113434 Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2011
Show all 9 generations
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  10. This deviceK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 22014: 1
2009high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009 · cites it directly5descendants
  • K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2010 · 2 generations on3descendants
  • K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2010 · 2 generations on3descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−8K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−7K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−6K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−5K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−4K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−3K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−2K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−1K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004—
0 (this device)K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC2007—
+1K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.2009—
+2K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.2010—
+2K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.2010—
+1K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC2011—
+1K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200120
200210
200310
200450
200530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201120
201410
FIG. 1 — Lineage of K071905, 1985–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052317Modification to: Stryker Spine Oasys System
Summary page 1
…liance Product Code / Classification Name KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis Regulatory Class Class II Predicate Devices K(052317, K032394 OASYSTM System Stryker Spine 1(052180, K003780 VERTEXTm Reconstruction System Medtron…
Stryker Spine2005—
*K032394Stryker Spine Oasys System
Summary page 1
…Product Code / Classification Name KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis Regulatory Class Class II Predicate Devices K(052317, K032394 OASYSTM System Stryker Spine 1(052180, K003780 VERTEXTm Reconstruction System Medtronic Sofamo…
Howmedica Osteonics Corp.2004—
*K052180Modification to Vertex Reconstruction System
Summary page 1
…inal Interlaminal Fixation Orthosis Regulatory Class Class II Predicate Devices K(052317, K032394 OASYSTM System Stryker Spine 1(052180, K003780 VERTEXTm Reconstruction System Medtronic Sofamor Danek…
Medtronic Sofamor Danek2005—
*K003780Vertex Reconstruction System
Summary page 1
…erlaminal Fixation Orthosis Regulatory Class Class II Predicate Devices K(052317, K032394 OASYSTM System Stryker Spine 1(052180, K003780 VERTEXTm Reconstruction System Medtronic Sofamor Danek USA, I…
Medtronic Sofamor Danek, Inc.2001—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 1
…Spine 1(052180, K003780 VERTEXTm Reconstruction System Medtronic Sofamor Danek USA, Inc. K(042508 Mountaineer OCT Spinal System Depuy Spine, Inc. K033961,K1(43229 Altius M-INI OCT System Int…
Depuy Spine, Inc.2004—
*K033961Altius Oct System
Summary page 1
…Sofamor Danek USA, Inc. K(042508 Mountaineer OCT Spinal System Depuy Spine, Inc. K033961,K1(43229 Altius M-INI OCT System Interpore Cross (now Biomet…
Interpore Cross Intl.2004—
*K043229Modification to Altius Oct System
Our reading of the summary gave K143229, FDA’s number for Nexis osteosynthesis compressive screws (Novastep), decided Feb 6, 2015, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Altius M-INI OCT System”.
Interpore Cross Intl.2004—
*K023675Synthes Cervifix/ Axon
Summary page 1
…e, Inc. K033961,K1(43229 Altius M-INI OCT System Interpore Cross (now Biomet Spine) K023675 Axon Synthes Spine K(030197 Ascent Blacks…
Synthes (Usa)2002—
*K030197Blackstone Posterior Cervical System
Summary page 1
…e Cross (now Biomet Spine) K023675 Axon Synthes Spine K(030197 Ascent Blackstone K(052201 Solanas Alphatec S…
Blackstone Medical, Inc.20031
*K052201Solanas Posterior Stabilization System
Summary page 1
…Spine) K023675 Axon Synthes Spine K(030197 Ascent Blackstone K(052201 Solanas Alphatec Spine Intended Use / Indications for Use When intend…
Alphatec Spine, Inc.20053

Also cleared against K052317: 6 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095
K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112
K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111
K140734Nextgen Altius Oct SystemEbi, LLC20140

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 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 26 ancestors have a recall of any class.
  • Of its descendants, K092656 (Lanx, Inc., 2009) has gone furthest, with 5 descendants of its own.
  • 6 other devices also cite its predicate K052317.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

When intended to promote fusion of the cervical spine and the thoracic spine (Cl-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) 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 * Fracture/Dislocation * Failed previous fusion…

Read the full statement (125 words)

When intended to promote fusion of the cervical spine and the thoracic spine (Cl-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) 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

* Fracture/Dislocation

* Failed previous fusion

* Tumor

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.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Indications for use as stated in the FDA summary.

Also cleared against K052317

6 other devices cite the same predicate.

  • K111719Oasys Spinal SystemStryker Spine · 2012
  • K101183Modification to: Oasys SystemStryker Spine · 2010
  • K093670Modification to: Oasys SystemStryker Spine · 20101 Class I recall
  • K080143Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  • K072568Modification to Oasys SystemStryker Spine · 2007
  • K062853Modification to Stryker Spine Oasys SystemStryker Spine · 2006

More from Lanx, LLC

13 FDA decisions under this applicant name. See the company

  • K120399Lanx Spinal Fixation SystemLanx, LLC · 2012
  • K102738Lanx Fusion SystemLanx, LLC · 20111 recall
  • K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2011
  • K093285Modification to Lanx Spinal Fixation SystemLanx, LLC · 2009
  • K082774Lanx Cervical Intervertebral Body Fusion DeviceLanx, LLC · 2008

Recent decisions in KWQ

The KWQ category page

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  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K071905 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071905: Posterior Cervicothoracic Spinal Fixation System (PCFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071905

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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