510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Synthes XRL

K103320510(k) TraditionalCleared Oct 20, 2011342-day reviewClass II21 CFR 888.3060Recalls 1

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

Synthes Spine Co.Lp · MQP Spinal Vertebral Body Replacement Device

Cleared on Oct 20, 2011 as substantially equivalent to K003275 (Synthes (Usa), 2001) and 4 other predicates after a 342-day review. Its family tree reaches back 3 generations to 1984. 3 later devices descend from it. It has been recalled once.

Decided
Oct 20, 2011
Review
342 days
Class
Class II
Product code
MQP
Recalls
1
Predicates
5

Its longest line of descent runs back 3 generations to K841189 (1984). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2001: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor2020: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalledK990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 19840
  1. Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 1 generation backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
  4. This deviceK103320 Synthes XRLSynthes Spine Co.Lp · 2011
  5. Descendant · cites it directly · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
  6. Descendant · 2 generations on · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
  7. Descendant · cites it directly · 0 of its ownK152460 Rectangular Corpectomy CageAmendia, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020 · cites it directly1descendant
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024 · 2 generations on0descendants
  • K152460Rectangular Corpectomy CageAmendia, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−2K990148Stackable Cage SystemDepuy Motech Acromed1999—
−1K003836Synthes Synex Spacer SystemSynthes200111
0 (this device)K103320Synthes XRLSynthes Spine Co.Lp2011—
+1K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG2020—
+2K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG2024—
+1K152460Rectangular Corpectomy CageAmendia, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200210
200410
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202010
202410
FIG. 1 — Lineage of K103320, 1984–2024Source: 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 MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (5)

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
*K003275Synthes Synmesh Spacer System
Summary page 1
…Class 11 Orthopedic and Rehabilitation Devices Panel Product Code: MQP Predicates: Synthes SynMesh Spacer System (K003275) Synthes Synex System (K003836) Synthes Contoured SynMesh (K041389) Alph…
Synthes (Usa)200114
*K003836Synthes Synex Spacer System
Summary page 1
…nd Rehabilitation Devices Panel Product Code: MQP Predicates: Synthes SynMesh Spacer System (K003275) Synthes Synex System (K003836) Synthes Contoured SynMesh (K041389) Alphatec NOVEL VBR Spinal System (K050553)…
Synthes200111
*K041389Synthes Contoured Synmesh Spacer
Summary page 1
…uct Code: MQP Predicates: Synthes SynMesh Spacer System (K003275) Synthes Synex System (K003836) Synthes Contoured SynMesh (K041389) Alphatec NOVEL VBR Spinal System (K050553) Synthes Oracle Spacer System (K062933) Device…
Synthes Spine20041
*K050553Novel VBR Spinal System
Summary page 1
…m (K003275) Synthes Synex System (K003836) Synthes Contoured SynMesh (K041389) Alphatec NOVEL VBR Spinal System (K050553) Synthes Oracle Spacer System (K062933) Device The Synthes XRL System is an addition to Synthes'…
Alphatec/Nexmed20051
*K062933Synthes Oracle Spacer
Summary page 1
…36) Synthes Contoured SynMesh (K041389) Alphatec NOVEL VBR Spinal System (K050553) Synthes Oracle Spacer System (K062933) Device The Synthes XRL System is an addition to Synthes' existing Description: thoracolumbar vertebral body r…
Synthes Spine Co.Lp2007—

Also cleared against K003275: 12 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201
K152460Rectangular Corpectomy CageAmendia, Inc.20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 8, 2014Class IIZ-1681-2014Process controlTwo lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K200235 (Icotec AG, 2020) has gone furthest, with 1 descendant of its own.
  • 12 other devices also cite its predicate K003275.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., LISS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft).

The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Indications for use as stated in the FDA summary.

Also cleared against K003275

12 other devices cite the same predicate.

  • K183054SYNMESH SystemDepuy Synthes Spine · 2019
  • K121176STGCCardinal Spine, LLC · 2012
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
  • K070381Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  • K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006
  • K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005

More from Synthes Spine Co.Lp

18 FDA decisions under this applicant name. See the company

  • K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
  • K112459Synthes Zero-PSynthes Spine Co.Lp · 2011
  • K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 20111 recall
  • K081568Antegra-TSynthes Spine Co.Lp · 2008
  • K080020ArcofixSynthes Spine Co.Lp · 2008

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K103320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103320: Synthes XRL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103320

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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