Product code LPH— Orthopedic
iNSitu Total Hip System
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Total cleared
- 564
- First cleared
- Most recent
Market context for product code LPH
FDA has cleared devices under product code LPH between 1984 and 2026, filed by 124 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code LPH
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 →
Recent clearances under product code LPH
1–100 of 564- K253630 — Mpact 3D Metal Foam
- K254043 — TRIVANCE Hip Stem
- K261624 — Omnifit® 20° Series I Insert +11 more
- K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
- K251270 — Taperloc® Complete Hip Stem
- K252623 — G7® Revision Acetabular System
- K251043 — Mpact 3D Metal Implants Extension DMLS Technology
- K252067 — Velora Acetabular System
- K252846 — TaperSet Hip System
- K251833 — EMPOWR Acetabular® Liner Extension
- K251718 — ArTT Augments and Buttresses and Bone Screws
- K250989 — Stryker and Serf hip devices
- K243456 — ONVOY Acetabular System
- K242744 — Trinity EVO Acetabular Shell
- K242232 — Mpact 3D Metal Augments II
- K242045 — Initia T3 Acetabular Hemispherical Shell System
- K243784 — Stryker Orthopaedics Hip Devices Labeling Update
- K243977 — EMPHASYS Acetabular System
- K241059 — Pantheon Proximal Femur Reconstruction (PFR) System
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K242833 — Legend® Acetabular Shell
- K242084 — EMPHASYS Acetabular Shell with RapiTite HA
- K242375 — OR3O Dual Mobility System
- K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips
- K231522 — EMPHASYS Dual Mobility System
- K233498 — Stryker Orthopaedics Hip Systems Labeling Update
- K232667 — OR3O Dual Mobility Liners
- K230011 — Mpact Extension
- K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
- K222436 — Latitud Hip Replacement System
- K222066 — LINK MobileLink Acetabular Cup System
- K223223 — BENCOX Mirabo Z Cup Cortinium
- K223779 — EMPOWR blade stem
- K223348 — My3D® Personalized Pelvic Reconstruction
- K211047 — CoCr Head
- K221675 — United U2 femoral head, 22mm delta ceramic head
- K213842 — ONVOY Acetabular System
- K220336 — Mg-PSZ Ceramic Femoral Head
- K221636 — EMPHASYS Acetabular System
- K220959 — OR3O Dual Mobility System
- K212815 — My3D® Personalized Pelvic Reconstruction
- K211176 — Smith & Nephew Hip Systems
- K201348 — DePuy 3D Additive TriFlange Acetabular Cup
- K210614 — BENCOX Mirabo Z Cup Cortinium
- K220468 — BENCOX Mirabo Cup System
- K212761 — Biocore9 Acetabular Cup System
- K220376 — Acetabular Dome Hole Plug
- K212187 — Restoration® Modular Hip System
- K211330 — R3 Large Head Liners
- K202568 — Mpact® 3D Metal Implants - DMLS Technology
- K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
- K201733 — Provident II Hip Stems
- K211866 — Bencox THR System
- K200607 — LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
- K200391 — MPACT Extension
- K210893 — Restoration Anatomic Shell
- K203557 — EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
- K202472 — ACTIS Duofix Hip Prosthesis
- K202484 — Cordera Hip System
- K200854 — DePuy PINNACLE Dual Mobility Liner
- K191708 — Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
- K200656 — Delta Multihole TT Pro Acetabular System
- K193233 — Restoration® Modular Hip System
- K191826 — KeYi Total Hip System
- K192450 — Precision Casting Solutions Total Hip System
- K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
- K190660 — G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
- K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis
- K192198 — Conformis Hip System
- K183457 — Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
- K191622 — Delta Multihole TT Pro Acetabular System
- K191002 — OR3O Dual Mobility System
- K190847 — REDAPT Blade Augments
- K191358 — Trident II Acetabular System
- K192071 — iNSitu Total Hip System
- K190904 — Conformis BeneFIT Hip System
- K191936 — iNSitu Total Hip System
- K183129 — Medtronic Total Hip Arthroplasty System
- K190123 — MicroPort CoCr Femoral Heads
- K190057 — DJO Acetabular System
- K182678 — Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
- K182221 — Bencox Mirabo Cup Multi Hole
- K183582 — MPACT Extension
- K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
- K182502 — Alteon Acetabular Cup System
- K190276 — Provident II Hip Stem
- K182099 — Delta TT Pro
- K182109 — REDAPT Modular Acetabular Shell
- K181366 — REDAPT Porous Acetabular Shell
- K172857 — Latitud Hip Replacement System
- K180798 — Prime Acetabular Cup System
- K172551 — Trinity PLUS Acetabular Shell
- K173951 — Legend Acetabular Liners
- K171966 — Mpact® 3D Metal Implants and Augments 3D Metal
- K172456 — Bone Screws 6.5mm
- K171934 — Birmingham Hip (BH) Dual Mobility Insert
- K171073 — Smith & Nephew, Inc. REDAPT Augments
- K172251 — UTS Stem
- K172806 — Bencox Mirabo Cup System
- K172684 — Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem
Data sourced from openFDA. This site is unofficial and independent of the FDA.