Company
Ossur H / F
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IQI | Orthosis, Limb Brace | 7 |
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 6 |
| KQZ | Component, Traction, Non-Invasive | 6 |
| IQK | Orthosis, Cervical | 4 |
| ISH | Component, External, Limb, Ankle/Foot | 2 |
| ITW | Joint, Ankle, External Brace | 2 |
| IPY | Orthosis, Lumbo-Sacral | 1 |
| ISY | Joint, Knee, External Limb Component | 1 |
| ITQ | Joint, Knee, External Brace | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2024 | Ossur H / F Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 Open, Classified |
IQK | None listed |
| May 10, 2024 | Ossur H / F RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| Jan 25, 2024 | Ossur H / F Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 Open, Classified |
ISW | None listed |
| Jun 13, 2023 | Ossur H / F Icelock 125 Ratchet, REF: L-125000;
Icelock 600XM Ratchet, REF: L-621200;
Icelock 621 Ratchet, REF: L-621000;
Icelock 621 Ratchet Adaption Kit, REF: L-621100;
Ratchet Lock Body, REF: L-692020 Open, Classified |
ISH | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Mar 14, 2016 | Ossur H / F Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. Terminated |
KQZ | None listed |
| Feb 24, 2016 | Ossur H / F Papoose Infant Spine Immobilizer
Item # Item Description:
PA-100 Papoose
PAR-100 Papoose w/replacement pads
PO-100 Papoose w/o PO front
POR-100 Papoose w/o PO front w/pad
Product Usage:
The Papoose Terminated |
IQK | None listed |
| Feb 24, 2016 | Ossur H / F Extreme Custom
Product Usage:
Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader Custom
Product Usage:
Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader Custom Lite
Product Usage:
Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Unloader XT
Product Usage:
Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Back Support Suspenders Clip on Black
Back Support Suspenders Sew on Black Terminated |
IPY | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Diabetic Walker
Product Usage:
Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. Terminated |
ITW | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Air Walker
Product Usage:
Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use. Terminated |
ITW | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Cartilage Custom
Product Usage:
Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Cartilage
Product Usage:
Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis. Terminated |
IQI | None listed |
| Feb 24, 2016 | Ossur H / F Miami J Collar
Product Usage:
Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization. Terminated |
IQK | None listed |
| Feb 24, 2016 | Ossur H / F NecLoc Extrication Collar
Product Usage:
Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization. Terminated |
IQK | None listed |
| Feb 24, 2016 | Ossur H / F Knee Undersleeve Gray
Product Usage:
Knee undersleeves are worn as an accessory for comfort under knee braces. Terminated |
ITQ | None listed |
| Feb 24, 2016 | Ossur H / F Knee Shield (Patella Cup)
Product Usage:
Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in m Terminated |
IQI | None listed |
| Mar 25, 2015 | Ossur H / F The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and envi Terminated |
ISW | None listed |
| Mar 17, 2015 | Ossur H / F LP Rotate Foot System prosthetic device for fitting lower extremity amputations.
-Low profile foot module with adjustable shock absorber and rotation
with progressive stiffening
-Build height: with Terminated |
ISH | None listed |
| Feb 6, 2012 | Ossur H / F Total Knee Junior Model Number 1100
Product Usage:
The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system. Terminated |
ISY | None listed |