# K993862: Modus Sagittal Split Plate

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: Dec 29, 1999 after 44 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954385 (1996). 3 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981890: Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates, Synthes (Usa) (1998) Summary page 1.
- K964328: Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate, Synthes (Usa) (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System, Elekta Instruments, Inc. (1995). Our OCR of the scanned summary read K946165, FDA’s number for CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation… (Elekta Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MODUS® System Plates and Mesh”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K022185: Universal CMF System (2002), 33 descendants of its own
- K031659: Universal Neuro System (2003), 12 descendants of its own
- K112557: Stryker Universal Neuro 3 System (2012), 9 descendants of its own
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), 4 descendants of its own
- K041651: Stryker Leibinger Skeletal Anchoring System (2004), 4 descendants of its own

## Indications for use
The MODUS® Titanium Osteosynthesis System is intended for use in oral maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

Source page: https://510kreport.com/device/K993862
Methodology: https://510kreport.com/methodology