510(k) · Cleared
Recalled · 2012Arcomxl Polyethylene Liners and 38/40MM Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 8, 2006 as substantially equivalent to K042051 (Biomet, Inc., 2005) and 4 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1988. It has been recalled 2 times.
- Decided
- Dec 8, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K881288 (1988). 29 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- 3 generations backK960538 Opteon UnipolarExactech, Inc. · 1996
- 2 generations backK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- 1 generation backK042037 M2A Magnum SystemBiomet, Inc. · 2004
- This deviceK062997 Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| −3 | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| −2 | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| −1 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| 0 (this device) | K062997 | Arcomxl Polyethylene Liners and 38/40MM Femoral Heads | Biomet Manufacturing Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K042051 | Arcomxl Polyethylene LinersSummary page 1…nonporous uncemented prosthesis (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ArComXL Tm Acetabular Liners- K042051 (Biomet, Inc.), ArCom®Acetabular Liners-K023357 (Biomet, Inc.), 36mm MaxRoM TM Acetabular Liners-K032396 (Biomet, Inc.), M2a Tm A… | 2005 |
| * | K023357 | Arcpm 1050 Resin-HipsSummary page 1…prosthesis (888.3353) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ArComXL Tm Acetabular Liners- K042051 (Biomet, Inc.), ArCom®Acetabular Liners-K023357 (Biomet, Inc.), 36mm MaxRoM TM Acetabular Liners-K032396 (Biomet, Inc.), M2a Tm Acetabular System-KO1111O (Biomet, Inc.), and M2a… | 2002 |
| * | K032396 | Ringloc 36MM Line and Modular Femoral HeadsSummary page 1…ubstantial Equivalence Is Claimed: ArComXL Tm Acetabular Liners- K042051 (Biomet, Inc.), ArCom®Acetabular Liners-K023357 (Biomet, Inc.), 36mm MaxRoM TM Acetabular Liners-K032396 (Biomet, Inc.), M2a Tm Acetabular System-KO1111O (Biomet, Inc.), and M2a Magnum tM System-K042037 (Biomet, Inc.) Device Descript… | 2003 |
| * | K011110 | M2A Acetabular System | 2001 |
| * | K042037 | M2A Magnum SystemSummary page 1…tabular Liners-K023357 (Biomet, Inc.), 36mm MaxRoM TM Acetabular Liners-K032396 (Biomet, Inc.), M2a Tm Acetabular System-KO1111O (Biomet, Inc.), and M2a Magnum tM System-K042037 (Biomet, Inc.) Device Description: Biomet Manufadturing Corp. isadding additional sizes and designs to the predicate ArComXL Tm… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2012 | Not classified | Z-1143-2012 | Employee error | Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings. |
| Sep 13, 2011 | Not classified | Z-1449-2012 | Nonconforming Material/Component | Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 4 of the 29 ancestors have a recall of any class.
- 6 other devices also cite its predicate K042051.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062997: Arcomxl Polyethylene Liners and 38/40MM Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062997
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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