Orthopedic · 510(k) · 2023
United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.. Cleared by FDA on 20 December 2023 under submission K230850, product code OOG (knee arthroplasty implantation system). What FDA's record says, in FDA's words.
Device record · K230850
- Device. United Orthopedic Knee Patient Specific InstrumentationDEVICE
- Company. Enhatch, Inc.COMPANY
- Decision. 20 December 2023, 510(k), substantially equivalent (traditional review); received 28 March 2023DECISION
- Panel. OrthopedicPANEL
- Product code. OOG, Knee Arthroplasty Implantation SystemCODE
- Regulation. 21 CFR 888.3560, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/3012023 See PRA Statement below. The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia. The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.
The product code's definition, from FDA's classification record. Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, radiographs (X-ray)
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 260 reports filed against devices carrying product code OOG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
11 September 2026 · Injury · Unknown component Aesculap AG Knee Implant System · AESCULAP AG · report 9610612-2026-00173
An adverse event was reported involving an unknown component of an Aesculap AG Knee Implant System.Specifically, it was reported that a revision surgery is required to replace a polyethylene component for an unspecified reason.According to manufacturer's reporting evaluation in accordance with 21 CFR Part 803, Section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days). The assessment for the reportability of this adverse event was based […]
27 August 2026 · Injury · Unknown component of an AESCULAP AG KNEE IMPLANT SYSTEM · AESCULAP AG · report 9610612-2026-00164
An adverse event was reported involving an unknown component of an Aesculap AG Knee Implant System. Specifically, it was reported that there was postoperative loosening of the right knee. This report pertains to the revision surgery performed on 2021-12-30 on the right knee. According to manufacturer's reporting evaluation in accordance with 21 CFR Part 803, Section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days). The assessment for […]
13 August 2026 · Injury · Unknown component Aesculap AG Knee Implant System · AESCULAP AG · report 9610612-2026-00160
An adverse event was reported involving an unknown component of an Aesculap AG Knee Implant System.Specifically, it was reported that a component of the knee implant system malfunctioned postoperatively.According to manufacturer's reporting evaluation in accordance with 21 CFR Part 803, Section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days). The assessment for the reportability of this adverse event was based on the patient harm, […]
5 August 2026 · Malfunction · TRUMATCH · DePuy Orthopaedics Inc US · report 1818910-2026-13382
3 August 2026 · Injury · Unknown component Aesculap AG Knee Implant System · AESCULAP AG · report 9610612-2026-00148
An adverse event was reported involving an unknown component of an Aesculap AG Knee Implant System.Specifically, it was reported that a component of the knee implant system malfunctioned postoperatively.According to manufacturer's reporting evaluation in accordance with 21 CFR Part 803, Section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days). The assessment for the reportability of this adverse event was based on the patient harm, […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OOG, in Orthopedic, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.