# K100802: Aesculap Implant Systems Sibd Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Jul 20, 2010 after 120 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 75 ancestors in all.
461 later devices descend from it; 1 cites it directly.
1 of 537 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008) Summary page 1.
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K091301: Life Spine Stand-Alone Spacer System, Life Spine (2009) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.

## Most influential descendants
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), 368 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K151214: ALIF Interfixated System (2015), 220 descendants of its own

## Indications for use
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used. As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with-degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). Patients should be 'skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

Source page: https://510kreport.com/device/K100802
Methodology: https://510kreport.com/methodology