# K050060: Laguna Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Allez Spine, LLC
- Decided: May 4, 2005 after 113 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981676 (1999). 1 ancestor in all.
21 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 1.

## Most influential descendants
- K072678: Laguna Size 8 Pedicle Screw (2008), 16 descendants of its own
- K103748: Laguna Pedicle Screw System (2011), 15 descendants of its own
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), 6 descendants of its own
- K152781: Adena-Zina System (2016), 5 descendants of its own

## Recalls of this device
- Aug 21, 2008 · Not classified · Z-0153-2009: This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regar
- Apr 14, 2008 · Not classified · Z-1819-2008: This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these para
- Nov 7, 2007 · Not classified · Z-2064-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2072-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2071-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2061-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2063-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2069-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2067-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2065-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2062-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2073-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2066-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2076-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2075-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2068-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2074-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2078-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2060-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2077-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Nov 7, 2007 · Not classified · Z-2070-2008: This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combin
- Jul 30, 2007 · Not classified · Z-0190-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Jul 30, 2007 · Not classified · Z-0189-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Jul 30, 2007 · Not classified · Z-0191-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Jul 30, 2007 · Not classified · Z-0186-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Jul 30, 2007 · Not classified · Z-0187-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Jul 30, 2007 · Not classified · Z-0188-2008: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.

## Indications for use
The Laguna Spinal System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K050060
Methodology: https://510kreport.com/methodology