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Synthes Pangea Monoaxial System

by Synthes Spine Co.Lp 510(k)

Active United States

510(k) K052151

Overview

The Synthes Pangea Monoaxial System is a posterior spinal fixation device classified as a monoaxial pedicle screw system. It is designed for use in the thoracic (T1) to sacral (S2) spine regions, providing segmental stabilization through pedicle screw fixation or hook fixation in the thoracic to lumbar (L5) spine. The system is intended for skeletally mature patients requiring surgical stabilization of the spine.

This device is supplied as a reusable surgical implant and is cleared for use under FDA 510(k) clearance (K052151) through the Traditional pathway. It is intended for use in orthopedic procedures and is categorized under product code NKB. The system is not single-use and requires proper sterilization and handling as per surgical protocols. No additional regulatory status beyond the stated FDA clearance is implied.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052151 Date7 Dec 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Synthes Pangea Monoaxial System used for?

    The Synthes Pangea Monoaxial System is designed for posterior spinal fixation in skeletally mature patients requiring surgical stabilization of the spine. It provides segmental stabilization in the thoracic (T1) through sacral (S2) regions, using either pedicle screw or hook fixation in the thoracic to lumbar (L5) spine. This system is intended to address spinal instability by securing vertebrae together, allowing for proper alignment and support during the healing process.

  • Is the Synthes Pangea Monoaxial System single-use or reusable?

    The Synthes Pangea Monoaxial System is a reusable surgical implant. It is not intended for single-use and must be properly sterilized and handled according to standard surgical protocols before each procedure. Reusability is a key feature for cost-effectiveness and infection control in operating environments.

  • What regions of the spine can the Pangea Monoaxial System stabilize?

    This system is specifically designed for use in the thoracic (T1) through sacral (S2) spine regions. It offers flexibility in fixation methods, including pedicle screws for lumbar and sacral segments and hook fixation for thoracic segments, ensuring targeted stabilization where needed.

  • How is the system sterilized and stored?

    Since the Synthes Pangea Monoaxial System is reusable, it must undergo proper sterilization between uses as per established surgical protocols. Storage should follow manufacturer guidelines to maintain sterility and integrity, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

  • What regulatory pathway was used for FDA clearance of this device?

    The Synthes Pangea Monoaxial System received FDA clearance through the Traditional 510(k) pathway, which evaluates whether the device is substantially equivalent to a legally marketed predicate device. The clearance number is K052151, and it falls under product code NKB for orthopedic spinal fixation devices.