PBF · Orthopaedic Surgical Planning And Instrument Guides

Device class

Class II

Regulation 888.3030

Total clearances

2020-03-11 → 2026-03-27

Last 12 months

Unique sponsors

Definition

What is Orthopaedic Surgical Planning And Instrument Guides

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3030

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Medcad	4	2	2026-03-27
Newclip Technics	4	1	2025-10-01
Bodycad Laboratories, Inc.	3	1	2025-10-21
3D Systems, Inc.	2	1	2025-12-05
Medacta International S.A.	2	1	2025-11-19
Smith & Nephew, Inc.	1	0	2024-03-18
Redpoint Medical, LLC	1	0	2022-06-09
3D Lifeprints UK , Ltd.	1	0	2023-02-01
KLS-Martin L.P.	1	0	2020-03-11
3D-Side S.A.	1	0	2021-11-29
Additive Orthopaedics, LLC	1	0	2022-06-28
Blue Belt Technologies, Inc.	1	0	2025-06-25
Centermed, Inc.	1	0	2022-08-04

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
20103	CPT	—	Medium	Surgical planning guides and instrument templates for orthopedic procedures; custom orthopedic surgical guide
27447	CPT	—	Low	Example orthopedic surgical procedure; specific code depends on actual procedure guided by system

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-27	K252064	Medcad	MedCAD® AccuStride System
2025-12-05	K250711	3D Systems, Inc.	VSP Orthopedics System
2025-11-19	K242603	Medacta International S.A.	MyPAO SA guides
2025-11-04	K251709	Medcad	MedCAD® AccuStride System
2025-10-21	K250394	Bodycad Laboratories, Inc.	Fine TTO
2025-10-01	K250767	Newclip Technics	Newclip Patient-matched instrumentation non sterile PSI
2025-06-25	K250921	Blue Belt Technologies, Inc.	CORIOGRAPH Pre-Op Planning and Modeling Services
2025-03-13	K241811	Medcad	MedCAD® AccuStride System
2025-02-13	K243912	Newclip Technics	Newclip Patient-matched instrumentation non sterile PSI
2024-11-07	K240415	Newclip Technics	Newclip Patient-matched instrumentation non sterile PSI
2024-03-18	K240113	Smith & Nephew, Inc.	CORIOGRAPH Knee Pre-Op Plan
2024-02-09	K240066	Bodycad Laboratories, Inc.	Fine Osteotomy
2023-10-25	K221615	Newclip Technics	Newclip Patient-matched instrumentation non sterile PSI
2023-09-20	K223421	Medcad	MedCAD AccuPlan Orthopedics System
2023-06-02	K231314	Bodycad Laboratories, Inc.	Fine Osteotomy
2023-05-30	K220706	Medacta International S.A.	MyPAO Guides
2023-02-01	K221943	3D Lifeprints UK , Ltd.	EmbedMed
2022-08-04	K211614	Centermed, Inc.	CenterMed Patient Matched Assisted Surgical Planning (ASP) System
2022-06-28	K211076	Additive Orthopaedics, LLC	Patient Specific Marking Guides
2022-06-09	K220717	Redpoint Medical, LLC	RedPoint Medical's Better Bunion System
2021-11-29	K212237	3D-Side S.A.	3D-Cut
2021-11-10	K211244	3D Systems	VSP® Orthopedics System
2020-03-11	K192979	KLS-Martin L.P.	KLS Martin Individual Patient Solutions (IPS) Planning System