# K121550: Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue Technology

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Aug 22, 2012 after 89 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801623 (1980). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120729: Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23, Ethicon Endo-Surgery, LLC (2012) Summary page 1.
- K050885: Olympus Ultrasonic Surgical System Sonosurg, Olympus Medical Systems Corporation (2005) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.

## Most influential descendants
- K161086: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) (2016), 0 descendants of its own
- K132566: Reprocessed Harmonic Shear (2014), 0 descendants of its own

## Recalls of this device
- May 3, 2018 · Class II · Z-2049-2018: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
- May 3, 2018 · Class II · Z-2048-2018: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

## Indications for use
The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint .space) and other open and endoscopic procedures.

Source page: https://510kreport.com/device/K121550
Methodology: https://510kreport.com/methodology