Company · US
Smith & Nephew, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2026. Name variants (Inc, Corp, punctuation) are merged.
551510(k) clearances (5 in 12 months)
449recalls (3 in 12 months)
332recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 109 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 67 |
| JDW | Pin, Fixation, Threaded | 61 |
| HRS | Plate, Fixation, Bone | 53 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 53 |
| LXH | Orthopedic Manual Surgical Instrument | 42 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 36 |
| HWC | Screw, Fixation, Bone | 33 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 31 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 26 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 23 |
| HRX | Arthroscope | 21 |
| JDS | Nail, Fixation, Bone | 20 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 19 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 18 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 18 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 17 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 16 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 16 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K263348 | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with Smith & Nephew, Inc. | MBI |
| Sep 8, 2026 | K261462 | LANDMARK Total Knee System Smith & Nephew, Inc. | MBH |
| Jul 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS Smith & Nephew, Inc. | MBI |
| Jul 6, 2026 | DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) Smith & Nephew, Inc. | SIQ |
| Apr 6, 2026 | K254084 | AETOS Shoulder System - CONCELOC Glenoids Smith & Nephew, Inc. | KWS |
| Oct 29, 2025 | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 Smith & Nephew, Inc. | KWS |
| Oct 3, 2025 | K252129 | AETOS Shoulder System Stemless Humeral Prosthesis Smith & Nephew, Inc. | PKC |
| Jun 25, 2025 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (# Smith & Nephew, Inc. | MBI |
| Jun 12, 2025 | K243608 | TRIGEN Stable Lock Nut & Washer Smith & Nephew, Inc. | JDS |
| Apr 2, 2025 | K250677 | LEGION Total Knee System Smith & Nephew, Inc. | JWH |
| Mar 28, 2025 | K250571 | CATALYSTEM Femoral Stems Smith & Nephew, Inc. | LZO |
| Feb 19, 2025 | K241666 | EVOS Pelvic and Acetabular System Smith & Nephew | HRS |
| Dec 9, 2024 | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail Smith & Nephew, Inc. | HSB |
| Nov 20, 2024 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis Smith & Nephew, Inc. | PKC |
| Oct 30, 2024 | K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) Smith & Nephew, Inc. | HSX |
| Oct 21, 2024 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems Smith & Nephew, Inc. | JDI |
| Oct 7, 2024 | K242375 | OR3O Dual Mobility System Smith & Nephew, Inc. | LPH |
| Sep 20, 2024 | K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System Smith & Nephew, Inc. | JDS |
| Sep 3, 2024 | K240487 | EVOS Patella Plates Smith & Nephew | HRS |
| Aug 22, 2024 | K241804 | TRIGEN INTERTAN 10S Nail System Smith & Nephew, Inc. | JDS |
| Jun 27, 2024 | K240381 | CATALYSTEM Femoral Stems Smith & Nephew, Inc. | LZO |
| Jun 20, 2024 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, wi Smith & Nephew, Inc. | MBI |
| Mar 18, 2024 | K240113 | CORIOGRAPH Knee Pre-Op Plan Smith & Nephew, Inc. | PBF |
| Mar 13, 2024 | K233949 | ACCORD Cable System Smith & Nephew, Inc. | JDQ |
| Jan 17, 2024 | K233730 | Footprint Mini PK, 3.5mm Suture Anchor Smith & Nephew | MBI |
| Dec 21, 2023 | K233396 | Cannulated Screw System Smith & Nephew, Inc. | HWC |
| Oct 27, 2023 | K232667 | OR3O Dual Mobility Liners Smith & Nephew, Inc. | LPH |
| Sep 8, 2023 | K232457 | Q-FIX ULTRA All-Suture Anchor Smith & Nephew | MBI |
| Aug 9, 2023 | K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) Smith & Nephew, Inc. | MBI |
| Aug 4, 2023 | K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobr Smith & Nephew, Inc. | MBI |
| Jul 19, 2023 | K231448 | TANDEM Hip System Smith & Nephew, Inc. | LZY |
| Jun 14, 2023 | K230761 | TRIGEN META-NAIL Nail System Smith & Nephew, Inc. | JDS |
| Jun 7, 2023 | K230572 | AETOS Shoulder System Smith & Nephew, Inc. | KWS |
| May 30, 2023 | K223762 | Smith & Nephew ACCORD Cable System Smith & Nephew | HRS |
| May 4, 2023 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR K Smith & Nephew, Inc. | JWH |
| Mar 30, 2023 | K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock Smith & Nephew, Inc. | JWH |
| Feb 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Smith & Nephew, Inc. | MBI |
| Jan 3, 2023 | K220847 | AETOS Shoulder System Smith & Nephew, Inc. | KWS |
| Dec 8, 2022 | K223112 | MAVERICK Mini External Fixation System Smith & Nephew, Inc. | JDW |
| Nov 14, 2022 | K210980 | Smith & Nephew Intramedullary Nail Systems Smith & Nephew, Inc. | HSB |
| Oct 28, 2022 | K222653 | JOURNEY II UK and ENGAGE Cementless Partial Knee System Smith+Nephew, Inc. | NJD |
| Oct 18, 2022 | K213123 | EVOS Wrist Spanning Plate Smith & Nephew, Inc. | HRS |
| Sep 29, 2022 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS) Smith & Nephew, Inc. | JDO |
| Sep 6, 2022 | K221929 | Smith+Nephew INTELLIO Tablet Smith+Nephew | ODA |
| Aug 25, 2022 | K221792 | Acute QC Strut and Components Smith & Nephew, Inc. | OSN |
| Aug 18, 2022 | K220959 | OR3O Dual Mobility System Smith & Nephew, Inc. | LPH |
| Jul 26, 2022 | K221939 | Cemented Round Patella with JRNY Pegs Smith & Nephew, Inc. | JWH |
| Jul 1, 2022 | K211176 | Smith & Nephew Hip Systems Smith & Nephew, Inc. | LPH |
| Apr 26, 2022 | K220896 | Legion Inserts with JRNY Lock Smith & Nephew, Inc. | JWH |
| Mar 11, 2022 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (H Smith & Nephew, Inc. | KWS |
Newest 50 of 551.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Smith & Nephew, Inc. EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM
REF72463106 Open, Classified |
HRS | K170457 K210837 +1 |
| Jun 16, 2026 | Smith & Nephew, Inc. TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 Open, Classified |
HSB | K210980 |
| Dec 18, 2025 | Smith & Nephew, Inc. BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Open, Classified |
HWC | K080358 K142948 |
| May 19, 2025 | Smith & Nephew, Inc. META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 Open, Classified |
HSB | K092748 K210980 |
| Nov 29, 2024 | Smith & Nephew Inc. BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Open, Classified |
MBI | K071586 K152566 |
| Nov 7, 2024 | Smith & Nephew, Inc. Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System. Open, Classified |
KWY | K023743 K211176 +1 |
| Oct 31, 2024 | Smith & Nephew Inc smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic Open, Classified |
JWH | K112941 |
| Oct 31, 2024 | Smith & Nephew Inc smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic Open, Classified |
JWH | K962557 |
| Oct 30, 2024 | Smith & Nephew Inc smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Open, Classified |
JWH | K043440 |
| Oct 30, 2024 | Smith & Nephew Inc smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Open, Classified |
JWH | K043440 |
| Sep 19, 2024 | Smith & Nephew, Inc. DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener Open, Classified |
HTY | None listed |
| Sep 19, 2024 | Smith & Nephew, Inc. DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener Open, Classified |
HTY | None listed |
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 72205201 Open, Classified |
GDW | K131637 |
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 2504-1 Open, Classified |
GDW | K131637 |
| May 24, 2024 | Smith & Nephew Inc smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4 Open, Classified |
LZO | K021673 K022958 |
| Oct 24, 2023 | Smith & Nephew, Inc. JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis Open, Classified |
JWH | K111711 K140555 |
| Oct 24, 2023 | Smith & Nephew, Inc. JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis Open, Classified |
JWH | K111711 K140555 |
| Sep 20, 2023 | Smith & Nephew Inc smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint Open, Classified |
JWH | K112941 K230653 |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail Open, Classified |
HSB | K040462 K210980 |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail Open, Classified |
HSB | K040462 K210980 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:
a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM;
b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM;
c) REF 1-10013-111, SIZ Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL;
b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL;
c) REF 1-10012-200, SIZE 2-LEF Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:
a) REF 1-10003-100 (SIZE 1 Right Medial);
b) REF 1-10003-110 (SIZE 1 Left Medial);
c) REF 1-10003-200 Open, Classified |
HSX | K190439 |
| Apr 14, 2023 | Smith & Nephew, Inc. JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM Open, Classified |
HSX | K190085 |
| Jun 27, 2022 | Smith & Nephew, Inc. (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186.
(2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166. Terminated |
JWH | K951987 |
| Apr 19, 2022 | Smith & Nephew Inc LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 Terminated |
JWH | K111711 K112941 |
| Jan 4, 2022 | Smith & Nephew, Inc. INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND Open, Classified |
HRS | K073375 |
| Dec 14, 2021 | Smith & Nephew, Inc. Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures
Product Number: 72205104 Open, Classified |
KQZ | None listed |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Terminated |
HRS | K201918 |
| Oct 25, 2021 | Smith & Nephew, Inc. Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile. Open, Classified |
HRS | K162078 |
| Sep 20, 2021 | Smith & Nephew, Inc. 6.5MMX165MM CANNULATED SCREW Terminated |
HWC | K060736 |
| May 19, 2021 | Smith & Nephew, Inc. LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis compon Terminated |
JWH | K043440 |
| Apr 8, 2021 | Smith & Nephew, Inc. CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014 Terminated |
MAI | K921481 |
| Dec 18, 2020 | Smith & Nephew, Inc. VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder Terminated |
LOD | K022688 |
| Nov 2, 2020 | Smith & Nephew, Inc. Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fract Terminated |
JDS | K040212 |
| Sep 21, 2020 | Smith & Nephew, Inc. 5.5MM Arthrogarde Hip Access Cannula Terminated |
NBH | None listed |
| Sep 21, 2020 | Smith & Nephew, Inc. Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral a Terminated |
JWH | K962137 |
| Sep 9, 2020 | Smith & Nephew, Inc. MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor
Product Number: 72204984 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor
Product Number: 72204983 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor
Product Number: 72203801 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor
Product Number: 72203708 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor
Product Number: 72203707 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor
Product Number: 72203706 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor
Product Number: 72203705 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor
Product Number: 72203704 Open, Classified |
MAI | K151105 |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor
Product Number: 72203697 Open, Classified |
MAI | K151105 |
Newest 50 of 449.