Conformis Hip System— 510(k) K192198
Substantially EquivalentConformis, Inc.
FDA 510(k) clearance K192198 for Conformis Hip System, Substantially Equivalent on 2019-11-06. Applicant: Conformis, Inc.. Device class: 2.
Clearance details
- Applicant
- Conformis, Inc.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Billerica, MA, US
Recent devices under product code LPH
view allMore clearances from Conformis, Inc.
view all- K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K231178 — ACTERA hip system
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192198
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192198.
Data sourced from openFDA. This site is unofficial and independent of the FDA.