510(k) Report

510(k) · Cleared

Cleared

Aesculap Peek Vertebral Body Replacement System

K060762510(k) TraditionalCleared Sep 14, 2006177-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

Aesculap, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Sep 14, 2006 as substantially equivalent to K031757 (Signus Medical, LLC, 2003) and 7 other predicates after a 177-day review. Its family tree reaches back 9 generations to 2001. 1 of the 824 devices in its family, counting itself, has a Class I recall. 789 later devices descend from it.

Decided
Sep 14, 2006
Review
177 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K003155 (2001). 34 ancestors in all, the oldest K841189 (1984). 789 later devices descend from it, 3 citing it directly. 1 of the 824 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 3 other ancestors2004: 5 other ancestors2003: 5 other ancestors2002: 3 other ancestors2001: 6 other ancestors1999: 1 other ancestor1984: 1 other ancestor2000: 1 other ancestor2015: 19 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2018: 53 descendants cleared2012: 5 descendants cleared2013: 6 descendants cleared2014: 16 descendants cleared2010: 2 descendants cleared2017: 48 descendants cleared2011: 4 descendants cleared2016: 28 descendants cleared2024: 90 descendants cleared2019: 69 descendants cleared2020: 74 descendants cleared2021: 69 descendants cleared, 1 with a Class I recall12025: 76 descendants cleared2022: 72 descendants cleared2023: 87 descendants cleared2026: 69 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 7 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 17 descendants3 generations forward: 46 descendants4 generations forward: 96 descendants5 generations forward: 145 descendants6 generations forward: 147 descendants7 generations forward: 152 descendants8 generations forward: 103 descendants, 1 with a Class I recall19 generations forward: 52 descendants10 generations forward: 20 descendants11 generations forward: 7 descendants12 generations forward: 1 descendant K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−50+5+10
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  4. 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  5. 1 generation backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  6. This deviceK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  7. Descendant · cites it directly · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  8. Descendant · cites it directly · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  9. Descendant · 2 generations on · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  10. Descendant · 3 generations on · 460 of its ownK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  11. Descendant · 4 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
Show all 9 generations
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations backK012254 VBROsteotech, Inc. · 2001
  3. 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 5 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 1 generation backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. This deviceK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006

Showing 5 of 789 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22011: 42012: 52013: 62014: 162015: 192016: 282017: 482018: 532019: 692020: 742021: 692022: 722023: 872024: 902025: 762026: 69
2008high 90 (2024) · low 1 (2008)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 789 · See all
  • K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · cites it directly788descendants
  • K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · cites it directly554descendants
  • K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · 2 generations on461descendants
  • K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011 · 3 generations on460descendants
  • K141942Midline II TICentinel Spine, Inc. · 2014 · 4 generations on459descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−8K012254VBROsteotech, Inc.2001—
−7K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−6K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−5K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−4K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−3K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−2K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
0 (this device)K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
+1K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
+1K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010—
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011—
+4K141942Midline II TICentinel Spine, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200160
200230
200350
200450
200530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201140
201250
201360
2014160
2015190
2016280
2017480
2018530
2019690
2020740
2021691
2022720
2023870
2024900
2025760
2026690
FIG. 1 — Lineage of K060762, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. 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? (8)

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
*K031757Peek Tetris Spinal Implant
Summary page 1
…IAL EQUIVALENCE Aesculap®, Inc. believes that the Aesculap PEEK VBR System is substantially equivalent to: 1) PEEK Tetris Spinal Implant by Signus Medical LLC (K031757) 2) Curved PEEK Tetris Spinal Implant by Signus Medizintechnik (K041888) 3) Rabea Spinal Implant by Signus Me…
Signus Medical, LLC2003—
*K041888Curved Peek Tetris Spinal Implant
Summary page 1
…tantially equivalent to: 1) PEEK Tetris Spinal Implant by Signus Medical LLC (K031757) 2) Curved PEEK Tetris Spinal Implant by Signus Medizintechnik (K041888) 3) Rabea Spinal Implant by Signus Medizintechnik (K043316) 4) Semial Spinal Implant by Signus Medical (KO516…
Signus Medizintechnik GmbH2004—
*K043316Rabea Spinal Implant
Summary page 1
…ignus Medical LLC (K031757) 2) Curved PEEK Tetris Spinal Implant by Signus Medizintechnik (K041888) 3) Rabea Spinal Implant by Signus Medizintechnik (K043316) 4) Semial Spinal Implant by Signus Medical (KO51659) 5) Nubic Spinal Implant by Signus Medical ((K052096)…
Signus Medizintechnik GmbH2005—
*K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005—
*K052096Nubic Spinal Implant
Summary page 1
…ea Spinal Implant by Signus Medizintechnik (K043316) 4) Semial Spinal Implant by Signus Medical (KO51659) 5) Nubic Spinal Implant by Signus Medical ((K052096) 6) Novel VBR Spinal System by Alphatec/ Nexmed (K042201) 7) Stryker Spine AVS PEEK Spacers (K042571) and (K0…
Signus Medical, LLC2005—
*K042201Novel VBR Spinal System
Summary page 1
…emial Spinal Implant by Signus Medical (KO51659) 5) Nubic Spinal Implant by Signus Medical ((K052096) 6) Novel VBR Spinal System by Alphatec/ Nexmed (K042201) 7) Stryker Spine AVS PEEK Spacers (K042571) and (K051205) DEVICE DESCRIPTION The Aesculap PEEK VBR System is a verteb…
Alphatec/Nexmed2004—
*K042571Stryker Spine Avs TL Peek Spacer
Summary page 1
…5) Nubic Spinal Implant by Signus Medical ((K052096) 6) Novel VBR Spinal System by Alphatec/ Nexmed (K042201) 7) Stryker Spine AVS PEEK Spacers (K042571) and (K051205) DEVICE DESCRIPTION The Aesculap PEEK VBR System is a vertebral body replacement device that is implanted into the…
Stryker Spine2005—
*K051205Stryker Spine Avs Asl Peek Spacer
Summary page 1
…Spinal Implant by Signus Medical ((K052096) 6) Novel VBR Spinal System by Alphatec/ Nexmed (K042201) 7) Stryker Spine AVS PEEK Spacers (K042571) and (K051205) DEVICE DESCRIPTION The Aesculap PEEK VBR System is a vertebral body replacement device that is implanted into the vertebral bod…
Stryker Spine2005—

Also cleared against K031757: 12 other devices →

What descends from it? (789)

See all 789

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

NumberDeviceApplicantDecidedDescendants
K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.2008788
K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554
K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 8 months on median.
  • 2 of the 34 ancestors have a recall of any class.
  • Of its descendants, K071983 (Aesculap Implant Systems, Inc., 2008) has gone furthest, with 788 descendants of its own.
  • 12 other devices also cite its predicate K031757.

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.

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 Aesculap PEEK Vertebral Body Replacement (VBR) System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK VBR System implants can be used individually or in pairs. The Aesculap PEEK VBR System is also intended for use with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K031757

12 other devices cite the same predicate.

  • K123758Tasmin RSignus Medizintechnik GmbH · 2014
  • K122317Tetris IISignus Medizintechnik GmbH · 2012
  • K070381Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  • K062151Box Peek VBR SystemInnovasis, Inc. · 2006
  • K061752Spinal Usa VBR SystemSpinal USA · 2006
  • K052670Staxx XD SystemSpine Wave, Inc. · 2006

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

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/K060762 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060762: Aesculap Peek Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060762

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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