# K982688: Spectrum Designs Pre-Form Contour Silicone Carving Block

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Designs, Inc.
- Decided: Oct 13, 1998 after 71 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Spectrum Designs Silicone Block Implant: named in the summary without a submission number
- (no number) Spectrum Designs Pectoral Implant: named in the summary without a submission number
- (no number) Silimed Elastomer, Silicone Block: named in the summary without a submission number
- (no number) SILIMED Calf Implant: named in the summary without a submission number

## Most influential descendants
- K071823: Perma Facial Implants (2007), 0 descendants of its own

## Indications for use
The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The pre-shaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.

Source page: https://510kreport.com/device/K982688
Methodology: https://510kreport.com/methodology