510(k) Report

510(k) · Cleared

Cleared

Xspan Laminoplasty Fixation System

K160114510(k) TraditionalCleared Mar 15, 201656-day reviewClass II21 CFR 888.3050

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

X-Spine Systems, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal

Cleared on Mar 15, 2016 as substantially equivalent to K103284 (Aesculap Implant Systems, Inc., 2010) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1976.

Decided
Mar 15, 2016
Review
56 days
Class
Class II
Product code
NQW
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K761228 (1976). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor1996: 2 other ancestors1985: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestorsK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963741 · Leibinger Luhr Small Craniomaxillofacial Bone Screws · Howmedica Leibinger, Inc. · 1997K032534 · Synthes Afs · Synthes Spine · 2004K090354 · Laminoplasty Plating System · Aesculap Implant System, Inc. · 2009K103284 · Laminoplasy Plating System · Aesculap Implant Systems, Inc. · 20101980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 5 other ancestors K103284 · Laminoplasy Plating System · Aesculap Implant Systems, Inc. · 2010K090354 · Laminoplasty Plating System · Aesculap Implant System, Inc. · 2009K032534 · Synthes Afs · Synthes Spine · 2004K963741 · Leibinger Luhr Small Craniomaxillofacial Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−50
  1. Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 4 generations backK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 3 generations backK032534 Synthes AfsSynthes Spine · 2004
  4. 2 generations backK090354 Laminoplasty Plating SystemAesculap Implant System, Inc. · 2009
  5. 1 generation backK103284 Laminoplasy Plating SystemAesculap Implant Systems, Inc. · 2010
  6. This deviceK160114 Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−4K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc.1997—
−3K032534Synthes AfsSynthes Spine2004—
−2K090354Laminoplasty Plating SystemAesculap Implant System, Inc.2009—
−1K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.2010—
0 (this device)K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198620
198810
199110
199410
199620
200910
FIG. 1 — Lineage of K160114, 1976–2016Source: 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 NQW? 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 NQW device

  1. #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K103284Laminoplasy Plating System
Summary page 5
…K160114 - Page 2 of 3 IV. PREDICATE DEVICES x Aesculap Implant Systems (AIS): AIS Laminoplasty Plating System (K103284; K090354) (Primary Predicate) o This predicate has not been subject to a design related recall. x…
Aesculap Implant Systems, Inc.2010—
*K090354Laminoplasty Plating System
Summary page 5
…K160114 - Page 2 of 3 IV. PREDICATE DEVICES x Aesculap Implant Systems (AIS): AIS Laminoplasty Plating System (K103284; K090354) (Primary Predicate) o This predicate has not been subject to a design related recall. x NuVasive Laminoplas…
Aesculap Implant System, Inc.2009—
*K091623Laminoplasty Fixation System
Summary page 5
…4; K090354) (Primary Predicate) o This predicate has not been subject to a design related recall. x NuVasive Laminoplasty Fixation System (K091623) o This predicate has not been subject to a design related recall. V. INTENDED USE The Xspan™ Laminoplasty Fi…
Nuvasive, Inc.2009—

What descends from it?

No later submission names this one as a predicate yet.

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 40 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
  • 1 of the 14 ancestors has a recall of any class.

How does its category compare?

All NQW devices

NQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NQW

2in 2024

2008: 12009: 22010: 32012: 42013: 32015: 12016: 22017: 12018: 22019: 22021: 12023: 22024: 22026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQW

84in 2013

2010: 120 days median2012: 120 days median2013: 84 days median
2007high 120 (2010) · low 84 (2013)2026

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

Recalls per year · NQW

No recall names NQW since 2007.

Adverse event reports per year · NQW

33in 2025

2009: 22012: 12013: 492014: 52015: 112016: 72017: 192018: 52019: 82020: 22021: 72022: 162023: 52024: 152025: 33
2007high 49 (2013) · low 0 (2007)2025

MAUDE reports naming product code NQW, 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
20070—00
20081—00
20092—02
2010312000
20110—00
2012412001
2013384049
20140—05
20151—011
20162—07
20171—019
20182—05
20192—08
20200—02
20211—07
20220—016
20232—05
20242—015
20250—033
20261—0—

What is it indicated for?

The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

Indications for use as stated in the FDA summary.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

Recent decisions in NQW

The NQW category page

  • K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
  • K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024
  • K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2023
  • K231232Curiteva Laminoplasty SystemCuriteva, Inc. · 2023

https://510kreport.com/device/K160114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160114: Xspan Laminoplasty Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160114

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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