# K043421: Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC

- Pathway: 510(k) (Traditional)
- Applicant: Regeneration Technologies, Inc.
- Decided: Feb 16, 2005 after 65 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pro Osteon Implant 500R Resorbable Bone Void Filler: named in the summary without a submission number

## Most influential descendants
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC (2008), 10 descendants of its own
- K091031: Pioneer Surgical Nanoss BVF-E (2009), 7 descendants of its own
- K110561: Fortross Bone Void Filler (2011), 4 descendants of its own
- K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit (2014), 3 descendants of its own
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own

## Recalls of this device
- Apr 26, 2019 · Class II · Z-1690-2019: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- Apr 26, 2019 · Class II · Z-1689-2019: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- Apr 26, 2019 · Class II · Z-1688-2019: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- Jan 23, 2017 · Class II · Z-1441-2017: Incorrect instructions for use (IFU) included.
- Dec 6, 2013 · Class II · Z-0939-2014: RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line refe
- Oct 14, 2005 · Not classified · Z-0482-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0488-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0484-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0485-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0495-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0483-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0489-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0501-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th

## Indications for use
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K043421
Methodology: https://510kreport.com/methodology