Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
FDA 510(k) K182705 · B-One Ortho, Corp.
510(k) numberK182705
Submission
- Device name
- Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
- Applicant
- B-One Ortho, Corp.
Cedar Knolls, NJ, US - Received
- September 27, 2018
- Decision date
- February 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | 09/08/2026SE |
| K253357 | b-ONE® Bipolar HeadKWY · Traditional | 04/13/2026SE |
| K240528 | b-ONE® Total Hip SystemLZO · Traditional | 11/15/2024SE |
| K222431 | b-ONER MOBIO Total Knee SystemJWH · Traditional | 10/06/2022SE |
| K213673 | b-ONE MOBIO Total Knee SystemJWH · Traditional | 01/21/2022SE |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…MAI · Traditional | 11/04/2021SE |
| K210483 | MOBIO Total Knee SystemJWH · Traditional | 04/21/2021SE |
| K202768 | KOSMO Femoral StemLZO · Traditional | 04/01/2021SE |
| K202429 | Mobio Total Knee SystemJWH · Traditional | 10/23/2020SE |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total…JWH · Traditional | 01/28/2019SE |
Questions and answers
When was Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups cleared by the FDA?
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (K182705) received a 510(k) decision of Substantially Equivalent on February 14, 2019, 140 days after the submission was received.
What is the product code of K182705?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.