510(k) · Cleared
Recalled · Class II · 2017Arcpm 1050 Resin-Hips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 6, 2002 as substantially equivalent to K950761 (Biomet, Inc., 1995) and 6 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1992. 480 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 1 generation to K920639 (1992). 7 ancestors in all. 480 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK920639 RX 90 Acetabular Component SystemBiomet, Inc. · 1992
- This deviceK023357 Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- Descendant · cites it directly · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- Descendant · 2 generations on · 286 of its ownK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
Showing 5 of 480 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 480 · See all- K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · cites it directly355descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 2 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 3 generations on343descendants
- K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · cites it directly289descendants
- K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007 · 2 generations on286descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920639 | RX 90 Acetabular Component System | Biomet, Inc. | 1992 | — |
| 0 (this device) | K023357 | Arcpm 1050 Resin-Hips | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| +2 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| +1 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| +2 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 12 | 0 |
| 2012 | 19 | 0 |
| 2013 | 30 | 0 |
| 2014 | 29 | 0 |
| 2015 | 22 | 0 |
| 2016 | 26 | 0 |
| 2017 | 21 | 0 |
| 2018 | 26 | 0 |
| 2019 | 34 | 0 |
| 2020 | 32 | 0 |
| 2021 | 31 | 0 |
| 2022 | 34 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 38 | 0 |
| 2026 | 34 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950761 | Index Acetabulat ComponentSummary page 8…age 8 === 510 (k) Number (if known) : )an33r7- Device Nama: Arcom0 Polyethylene Liners and Components Indications for Use: The products found in the orlginaf 51O(k) K950761, and K954417 will use the following Indicatioki for Use: 1) Nonlnflamrnatory degenerative joint disease including osteoarthri… | 1995 |
| * | K954417 | A-B Acetabular ComponentSummary page 8…(k) Number (if known) : )an33r7- Device Nama: Arcom0 Polyethylene Liners and Components Indications for Use: The products found in the orlginaf 51O(k) K950761, and K954417 will use the following Indicatioki for Use: 1) Nonlnflamrnatory degenerative joint disease including osteoarthritis and… | 1995 |
| * | K920639 | RX 90 Acetabular Component SystemSummary page 9….. 510 (k) Number (if known) : )coC,33~7- Device Name: Arcom@ Polyethylene Uners and Components' Indications'for Use: The products found in the orlginal SlO(k) K920639, K920640 and K926107 will use the following Indications for Use: 1) Noninflammatory degenerative jolnt disease including ost… | 1992 |
| * | K920640 | Full Hemisphere Ring-Loc LinerSummary page 2…1 Pevlce Descrlption Indications for Uge Ringloc UHMWPE Hi- 1. Noninflammatory degenerative joint disease K920640 Wall including osteoarthritis and avascular necrosis, X(9f6107 22,26,28, and 32 mm… | 1992 |
| * | K926107 | Arcom Polyethylene Acetabular Liners & ComponentsSummary page 9…(if known) : )coC,33~7- Device Name: Arcom@ Polyethylene Uners and Components' Indications'for Use: The products found in the orlginal SlO(k) K920639, K920640 and K926107 will use the following Indications for Use: 1) Noninflammatory degenerative jolnt disease including osteoarthritis and… | 1993 |
| * | K921274 | Metallic Toatal Hip SystemSummary page 2…+5 Deep 28mm For Cemented use only 1) Noninflammatory degenerative joint disease K921274 Impact Hi-Wall including osteoarthritis and avascular necrosis, 28 and 32mm… | 1994 |
| * | K970501 | Pegged Acetabular ComponentSummary page 11…nents . . .. . . . Indicktlons-fw Use: The products found in the original 510(k) K970501 will u& the . .. follohng Indications fbr Use: Intended for use in reconstruction of the hip joint due to d… | 1997 |
What descends from it? (480)
See all 4805 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2017 | Class II | Z-1860-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 7 ancestors has a recall.
- Of its descendants, K042051 (Biomet, Inc., 2005) has gone furthest, with 355 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement…
Read the full statement (286 words)
The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2) Rheumatoid arthritis,
3) Correction of functional deformity,
4) Revision procedures where other treatments or devices have failed and
5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Cemented and Non-cemented use
The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2) Rheumatoid arthritis,
3) Correction of functional deformity,
4) Revision procedures where other treatments or devices have failed and
5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Cemented use only
The products found in the original 510(k) K921274 will use the following Indications for Use:
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2) Rheumatoid arthritis,
3) Correction of functional deformity,
4) Revision procedures where other treatments or devices have failed and
5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Non-Cemented use only
The products found in the original 510(k) K970501 will use the following Indications for Use:
Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.
The device is a single use implant
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023357: Arcpm 1050 Resin-Hips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026