# Ellipse Technologies, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 20 (2011–2016): 20 510(k) clearances
- Names in FDA's records: Ellipse Technologies, Inc. (13); Ellipse Technologies, Incorporated (7)
- Product codes: HSB (15), PGN (4), KCT (1)
- 510(k) review time since 2016: median 59 days, against 124 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 27 (22 its own); citations of its devices by later devices: 46 (22 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Containmed, Inc.: 1 (https://510kreport.com/company/containmed)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Orthodyne, Inc.: 1 (https://510kreport.com/company/orthodyne)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)

## Firms that cite its devices most
- Nuvasive Specialized Orthopedics, Inc.: 19 (https://510kreport.com/company/nuvasive-specialized-orthopedics)
- Wittenstein Intens GmbH: 4 (https://510kreport.com/company/wittenstein-intens)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K131677: Precice Intramedullary Limb Lengthening System (2013), cited by 6
- K101997: Ellipse Intramedullary Limb Lengthening System (2011), cited by 6
- K133289: Precice Intramedullary Limb Lengthening System (2013), cited by 5
- K141023: Precice Intramedullary Limb Lengthening System (2014), cited by 4
- K150885: MAGEC 2 Spinal Bracing and Distraction System (2015), cited by 4
- K140178: Ellipse Magec Spinal Bracing and Distraction System (2014), cited by 4

## Recent decisions
- K160325: PRECICE Intramedullary Limb Lengthening System (Apr 4, 2016)
- K160267: PRECICE Trauma Nail System (Mar 31, 2016)
- K151594: Ellipse Supplemental Instrument Trays (Jan 25, 2016)
- K152370: PRECICE Trauma Nail System (Dec 22, 2015)
- K151131: PRECICE Intramedullary Limb Lengthening System (Jun 19, 2015)
- K150885: MAGEC 2 Spinal Bracing and Distraction System (May 29, 2015)
- K150656: PRECICE Intramedullary Limb Lengthening System (Apr 23, 2015)
- K141278: Magec Spinal Bracing and Distraction System (Mar 24, 2015)

Source page: https://510kreport.com/company/ellipse-technologies