Smart SPACE Shoulder Planner and 3D Positioners
FDA 510(k) K222405 · Lima Corporate S.P.A.
510(k) numberK222405
Submission
- Device name
- Smart SPACE Shoulder Planner and 3D Positioners
- Applicant
- Lima Corporate S.P.A.
Villanova Di San Daniele Del Friuli, IT - Received
- August 9, 2022
- Decision date
- December 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHE – Shoulder Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Other 510(k)s with product code QHE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | Materialise NV | 06/09/2026SE |
| K261510 | Signature ONE SystemQHE · Special | Orthosoft Inc. (d/b/a) Zimmer CAS | 06/04/2026SE |
| K260104 | Signature ONE SystemQHE · Special | Orthosoft Inc. (d/b/a) Zimmer CAS | 02/04/2026SE |
| K251558 | Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional | Precision AI Pty, Ltd. | 01/12/2026SE |
| K243509 | Archer PSI SystemQHE · Traditional | 3D-Side | 05/12/2025SE |
| K241470 | CORE Shoulder SystemQHE · Traditional | LinkBio Corp. | 02/20/2025SE |
| K243955 | Precision AI Surgical Planning System (PAI-SPS)QHE · Special | Precision AI Pty, Ltd. | 01/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | Materialise NV | 10/18/2024SE |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System SoftwareQHE · Traditional | Arthrex, Inc. | 10/02/2024SE |
| K233992 | Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional | Precision AI Pty, Ltd. | 08/05/2024SE |
More from Precision AI Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemPHX · Traditional | 01/22/2026SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | 08/29/2025SE |
| K243826 | SMR Reverse HP Shoulder SystemPHX · Traditional | 07/03/2025SE |
| K250980 | Physica System (Physica CR Porous Femoral components)MBH · Traditional | 05/22/2025SE |
| K243615 | Physica Porous Femoral ComponentsMBH · Special | 12/18/2024SE |
| K234011 | AMF TT ConesJWH · Special | 01/18/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | 12/21/2023SE |
| K231925 | MINIMA S SystemLZO · Special | 07/11/2023SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | 03/17/2023SE |
Questions and answers
When was Smart SPACE Shoulder Planner and 3D Positioners cleared by the FDA?
Smart SPACE Shoulder Planner and 3D Positioners (K222405) received a 510(k) decision of Substantially Equivalent on December 20, 2022, 133 days after the submission was received.
What is the product code of K222405?
The FDA product code is QHE – Shoulder Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.