# K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Sep 28, 1995 after 71 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 8 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K121624: Biomet Microfixation Neuro Plating System (2012), 5 descendants of its own
- K121589: Biomet Microfixation Facial Plating System (2012), 5 descendants of its own
- K031989: Ortrautek Orthognathic System (2003), 5 descendants of its own
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems (2010), 4 descendants of its own

## Recalls of this device
- Nov 8, 2010 · Not classified · Z-0835-2012: On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) 
- Nov 8, 2010 · Not classified · Z-0836-2012: On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) 
- Jul 28, 2010 · Not classified · Z-2385-2011: Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the p
- May 17, 2010 · Not classified · Z-2873-2011: On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some
- Apr 26, 2010 · Not classified · Z-1286-2012: On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
- Mar 17, 2010 · Not classified · Z-2206-2010: Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
- Oct 6, 2009 · Not classified · Z-1151-2010: Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, C
- Oct 5, 2009 · Not classified · Z-1943-2010: Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

Source page: https://510kreport.com/device/K953385
Methodology: https://510kreport.com/methodology