Skip to content

Paradigm System

by Proprio, Inc. 4 variants

510(k) K250879

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250879 Date4 Jun 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Paradigm System is a stereotaxic spinal instrument guidance device, classified under the FDA product code OLO. It integrates multimodal sensors, light-field computer vision, and real-time 3D visualization to assist in precise surgical navigation during spine procedures. Designed for orthopedic applications, it enhances surgical accuracy by providing structured data integration and AI-driven guidance. The device is intended for use in spinal interventions requiring enhanced spatial orientation and instrument alignment.

The Paradigm System is supplied as a reusable medical device and is cleared for use in operating room settings. It does not require sterilization between uses as per standard reusable medical device protocols. The system is regulated under the FDA’s Traditional 510(k) pathway, with clearance granted through the Orthopedic Devices Advisory Committee (OR). No specific MRI safety classification or single-use designation is indicated in the available data.

Devices cleared under K250879

30 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250879
UDI-DISize and differences
Paradigm 1100004
Proprio
1100004 / 110000400850042604106
Single use: no
On the market
Paradigm 1100006
Proprio
1100006 / 110000600850042604014
Single use: no
On the market
Paradigm 1200003
Proprio
1200003 / 120000300850042604052
Single use: no
On the market
Paradigm 1200004
Proprio
1200004 / 120000400850042604069
Single use: no
On the market
Paradigm 1200005
Proprio
1200005 / 120000500850042604076
Single use: no
On the market
Paradigm 1200006
Proprio
1200006 / 120000600850042604083
Single use: no
On the market
Paradigm 1200008
Proprio
1200008 / 120000800850042604151
Single use: no
On the market
Paradigm 1200009
Proprio
1200009 / 120000900850042604021
Single use: no
On the market
Paradigm 1200010
Proprio
1200010 / 120001000850042604144
Single use: no
On the market
Paradigm 1200011
Proprio
1200011 / 120001100850042604113
Single use: no
On the market
Paradigm 1200012
Proprio
1200012 / 120001200850042604120
Single use: no
On the market
Paradigm 1200013
Proprio
1200013 / 120001300850042604168
Single use: no
On the market
Paradigm 1200014
Proprio
1200014 / 120001400850042604175
Single use: no
On the market
Paradigm 1200015
Proprio
1200015 / 120001500850042604182
Single use: no
On the market
Paradigm 1200016
Proprio
1200016 / 120001600850042604199
Single use: no
On the market
Paradigm 1200017
Proprio
1200017 / 120001700850042604205
Single use: no
On the market
Paradigm 1200018
Proprio
1200018 / 120001800850042604212
Single use: no
On the market
Paradigm 1200019
Proprio
1200019 / 120001900850042604229
Single use: no
On the market
Paradigm 1200029
Proprio
1200029 / 120002900850042604137
Single use: no
On the market
Paradigm 1300001
Proprio
1300001 / 130000100850042604267
Single use: yes
On the market
Paradigm Depth Cannula, 2mm 1200027
Proprio
1200027 / 120002700850042604304
Single use: no
On the market
Paradigm Depth Cannula, 5mm 1200030
Proprio
1200030 / 120003000850042604328
Single use: no
On the market
Paradigm Drill Bit, 2.1 mm 1200025
Proprio
1200025 / 120002500850042604281
Single use: yes
On the market
Paradigm Drill Bit, 3.0 mm 1200026
Proprio
1200026 / 120002600850042604298
Single use: yes
On the market
Paradigm Drill Guide Trocar 1200028
Proprio
1200028 / 120002800850042604311
Single use: no
On the market
Paradigm Navigated Drill Guide 1200024
Proprio
1200024 / 120002400850042604274
Single use: no
On the market
Paradigm Navigated Drill Guide Case Assembly 1200021
Proprio
1200021 / 120002100850042604342
Single use: no
On the market
Paradigm Navigated Drill Guide Case Lid 1200023
Proprio
1200023 / 120002300850042604243
Single use: no
On the market
Paradigm Navigated Drill Guide Case Tray 1200022
Proprio
1200022 / 120002200850042604236
Single use: no
On the market
Paradigm Navigated Drill Guide Set 1200020
Proprio
1200020 / 120002000850042604335
Single use: no
On the market

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

Other devices from Proprio

See all devices from Proprio →